Isopropyl Palmitate/White Soft Paraffin 2031 Light Liquid Paraffin Preparations Yellow Soft Paraffin Dünnflüssiges Paraffin; Hígan folyó paraffin; Huile de Vaseline Flu- BP 2008: Cetomacrogol Emulsifying Ointment; Cetrimide Emulsifying Keltavaseliini; Minkštasis geltonas parafinas; Paraff. Moll. Flav.; Par- Ointment; Emulsifying Ointment; Light Liquid Paraffin Eye Drops; Liquid ide; Light Liquid Petrolatum; Light Mineral Oil; Light White Min- Paraffin and Magnesium Hydroxide Oral Emulsion; Liquid Paraffin Oral affinum Molle Flavum; Petrolatum; Petroleum Jelly; Sárga vazelin; eral Oil; Paraff. Liq. Lev.; Paraffin, lättflytande; Paraffine liquide Emulsion; Simple Eye Ointment; Wool Alcohols Ointment; Vaselin, gult; Vaselina Amarela; Vaselina amarilla; Vaselina filante légère; Paraffinum Liquidum Leve; Paraffinum Liquidum Tenue; USP 31: Bland Lubricating Ophthalmic Ointment; Mineral Oil Emulsion; amarilla; Vaseline jaune; Vaselinum flavum; Vazelína žlutá; Wazeli- Mineral Oil, Rectal; Topical Light Mineral Oil. Paraffinum perliquidum; Parafiini, kevyt nestemäinen; Parafin na z˙ółta; Yellow Petrolatum; Yellow Petroleum Jelly. tekutý lehký; Skystasis lengvas parafinas; Spray Paraffin; Vaselina Proprietary Preparations (details are given in Part 3) Arg.: Babix; Lansoyl; Lax Ewe Jalea; Laxante Arceli; Laxuave Enteral; Laxuave Жёлтый Вазелин líquida. Jalea; Lexavite†; Lubritina Franklin; Modaton NI; Oilatum; Austral.: Agarol; CAS — 8009-03-8. ATC — A06AA01. Hamilton Skin Therapy; Oilatum Bar; Oilatum Emollient; Oilatum Shower ATC Vet — QA06AA01. Gel; Belg.: Lansoyl; Braz.: Nujol; Canad.: Fleet Enema Mineral Oil; Lan- Pharmacopoeias. In Chin., Eur. (see p.vii), Int., Jpn, and US. soyl; Nujol; Chile: Laxonarol; Cz.: Oilatum Emollient; Oilatum Gel; Fr.: Lan- Many pharmacopoeias use the title Vaselinum Flavum; in some In Eur. (see p.vii) and Jpn. Also in USNF. soyl; Laxamalt†; Lubentyl; Oilatum Emollient; Oilatum Soap†; Restrical; Pharmacopoeias. countries the name ‘Vaseline’ is a trade-mark. US also includes Topical Light Mineral Oil . Ger.: Agarol N†; Obstinol M; Gr.: Agarol Plain; Nujol; Paragel; Hong Ph. Eur. 6.2 (Paraffin, Yellow Soft). A purified mixture of semi- . A purified mixture of liquid Kong: Agarol; Hamilton Body Wash; Keri; Oilatum Bar; Oilatum Emollient; Ph. Eur. 6.2 (Paraffin, Light Liquid) Oilatum Gel; Vigarol; Indon.: Oilatum Bar; Oilatum Gel; Irl.: Alcoderm†; solid hydrocarbons obtained from petroleum. A yellow, translu- saturated hydrocarbons obtained from petroleum. It is a transpar- Oilatum Gel; Oilatum Junior; Oilatum Soap; Ital.: Agarol CM†; Duratirs†; cent, unctuous mass, slightly fluorescent in daylight when melt- ent, colourless, oily liquid, free from fluorescence in daylight. Malaysia: Balneum; Egozite Protective Baby Lotion; Laxaron†; Oilatum; ed. It has a drop point of 40° to 60°. Practically insoluble in wa- Relative density 0.810 to 0.875. Viscosity 25 to 80 mPa s. Prac- NZ: Fleet Mineral Enema†; Oilatum; Philipp.: Oilatum; Pol.: Oilatum; S.Afr.: Oilatum Bar; Oilatum Emollient; Singapore: Balneum; Laxarol; Nu- ter, in alcohol, and in glycerol; slightly soluble in tically insoluble in water; slightly soluble in alcohol; miscible traderm†; Oilatum Bar; Oilatum Emollient; Oilatum Gel; Spain: Emuliquen dichloromethane. Protect from light. with hydrocarbons. Protect from light. Simple; Hodernal; Switz.: Lansoyl; Laxamalt; Paragol N; Thai.: Agarol; Oil- USP 31 (Petrolatum). A purified mixture of semi-solid hydro- . A purified mixture of liquid hy- atum Bar; Oilatum Emollient; Oilatum Gel; Turk.: Duratears; Sokol; UK: USNF 26 (Light Mineral Oil) carbons obtained from petroleum. It may contain a suitable sta- drocarbons obtained from petroleum. It may contain a suitable Cetraben Emollient; Dermamist; Keri; Oilatum Bath Formula; Oilatum Fra- grance Free; Oilatum Gel; Oilatum Junior; Oilatum Soap; Zerobase; USA: biliser. It is an unctuous yellowish to light amber mass, having stabiliser. It has similar characteristics to Mineral Oil but a lower Kondremul; Liqui-Doss. not more than a slight fluorescence even after being melted. It is kinematic viscosity. Store in airtight containers. Protect from Multi-ingredient: Arg.: Agarol; Alcon Lagrimas; Aqualane; Cold Cream transparent in thin layers. It is free or practically free from odour. light. Naturel†; Mil-Par; Usar Fibras†; Austral.: Alpha Keri; DermaVeen Shower & Bath; Dermeze; Duratears; E45; Egozite Baby Cream; Granugen; Hamil- M.p. 38° to 60°. Insoluble in water; practically insoluble in cold Adverse Effects and Precautions ton Body Lotion†; Hamilton Cleansing Lotion†; Hamilton Dry Skin; Lacri- or hot alcohol and in cold dehydrated alcohol; freely soluble in Excessive oral or rectal dosage with liquid paraffin may result in Lube; Oilatum Plus; Parachoc; Pinetarsol; Rikoderm†; Soov Prickly Heat; benzene, in carbon disulfide, in chloroform, and in turpentine oil; anal seepage and irritation, excessive purgation, and watery diar- Austria: Balneum F; Neda Fruchtewurfel; Belg.: Duratears; Lacrytube; soluble in ether, in petroleum spirit, and in most fixed and vola- Tulle Vaseline†; Braz.: Agarol; Balmex; Fenogar†; Parapsyl; Canad.: Agarol rhoea. Liquid paraffin is absorbed to a slight extent and may give Plain; Akwa Tears; Alpha Keri†; Duolube; Duratears†; Episec; Huile de Bain tile oils. rise to foreign-body granulomatous reactions. Similar reactions Therapeutique; Hypotears; Lubriderm Advanced Moisture†; Lubriderm†; have followed the injection of liquid paraffin and may be consid- Magnolax; Oilatum; Optilube; Penederm†; Puralube†; Refresh Lacri-Lube; Adverse Effects erably delayed in onset. Injection may also cause vasospasm and Tears Naturale PM; Therapeutic Bath Oil†; Therapeutic Skin Lotion†; Adverse effects of soft paraffin are rare when used in topical prompt surgical removal may be required to prevent severe dam- Chile: Acnaid; Acnoxyl Jabon†; Agarol; Cold Cream Avene; Durasolets; preparations, but sensitivity reactions and acne have been report- Duratears; Lacri-Lube; Cz.: Balmandol; Balneum Hermal F; Oilatum Plus; ed after topical use. Granulomatous reactions after absorption or age. Lipoid pneumonia has been reported after aspiration of liq- Denm.: Ojensalve Neutral; Fin.: Lacri-Lube; Fr.: Cerat Inalterable; Cold uid paraffin. Because of the risk of aspiration, oral liquid paraffin Cream Naturel; Dexeryl; Lubentyl a la Magnesie; Melaxose; Oilatum Body injection and lipoid pneumonia after aspiration have occurred. should not be given to patients who have difficulty swallowing, Oil†; Oilatum Cream†; Parapsyllium; Transulose; Ger.: Allergika†; Balneum Fire risk. Burns to the scalp, face, and hands have been F; Cellosorb; Coliquifilm; Excipial; Gleitgelen; Oleobal; Parfenac Basisbad†; 1 or to those with impaired neurodevelopment. Vita-POS; Windol Basisbad†; Gr.: Duratears; Hong Kong: Alpha Keri; Bal- reported in 5 patients who accidentally ignited their hair after Some licensed product information warns that chronic ingestion neum; Duratears; Ego Skin Cream; Egozite Baby Cream; Hydromol†; Oila- the application of paraffin-based hair grease. Four patients suf- of liquid paraffin may rarely be associated with impaired absorp- tum Cream; Oilatum Plus; Polytar Emollient; Soov Prickly Heat; India: Aga- fered inhalation injury, 2 of whom required intubation. The death tion of fat-soluble vitamins and possibly other compounds. rol†; Cetraben; Cremaffin; Easylax; Indon.: Laxadine; Oilatum Plus; Yanthi of a patient who, while smoking, ignited bandages covering a Baby Oil; Irl.: Emulsiderm; Hydromol†; Lacri-Lube; Oilatum Emollient; Oil- 2 There is little published evidence to support this. Prolonged use atum Junior; Oilatum Junior Flare-Up; Oilatum Plus; Polytar Emollient†; Is- paraffin-based ointment for psoriasis, prompted the BNF to rec- should, however, be avoided. Liquid paraffin should not be used rael: Balneum F; CleanEars; Duratears; Emulsiderm; Lacrimol; Ital.: Bal- ommend that patients should be told not to smoke and to keep when abdominal pain, nausea, or vomiting is present. The UK neum Hermal Forte; Duolaxan†; Lacrilube; Malaysia: Balneum; Duratears away from flames when using paraffin-based emollients. Naturale; Ego Skin Cream; Egozite Baby Cream; Lacrilube†; Oilatum; Oila- CSM considers that it should not be used in children under 3 tum Plus Antibacterial; QV Flare Up; Soov Prickly Heat†; Mex.: Acuafil†; 1. Bascom R, et al. Inhalation injury related to use of petrolatum- years of age. Milpar; Neth.: Duratears Z; Transulose; Norw.: Simplex; NZ: Alpha Keri; based hair grease. J Burn Care Rehabil 1984; 5: 327–30. BK; DP; DP Lotion - HC; Ego Skin Cream; Egozite Baby; Hydroderm; Kari- 2. National Patient Safety Agency. Skin treatment fire risk. Patient Granuloma. References. care Breast and Body Cream†; Lacrilube; Oilatum Plus; Poly-Visc; Polytar Safety Bulletin 2007 (Jan.); 4. Available at: http:// 1. Di Benedetto G, et al. Paraffin oil injection in the body: an obso- Emollient; Philipp.: Oilatum; Oilatum Plus; Pol.: Amfobase; Balneum Her- www.npsa.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=6341 lete and destructive procedure. Ann Plast Surg 2002; 49: 391–6. mal F; Diprobase; E45; Mentho-Paraffinol; Oilatum Plus; Unibasis; Port.: (accessed 29/08/08) Banholeum Gele; Betacade†; Melaxose; Oleoban Gel†; S.Afr.: Oilatum Lipoid pneumonia. References. Plus; Singapore: Balneum; DermaVeen Shower & Bath; Duratears; Ego Hypersensitivity. The allergenicity of soft paraffin products 1. Becton DL, et al. Lipoid pneumonia in an adolescent girl second- Skin Cream; Egozite Baby Cream; Egozite Protective Baby Lotion†; Lac- has been investigated.1-4 Considering their widespread use there ary to use of lip gloss. J Pediatr 1984; 105: 421–3. rilube; Oilatum Plus; QV Flare Up; Soov Prickly Heat†; Spain: Aceite Aca- 4 lorico; Emuliquen Laxante; Lubrifilm; Vaselatum; Switz.: Antidry; Balman- are very few reports of sensitivity; of nearly 80 000 patients 2. Ohwada A, et al. Exogenous lipoid pneumonia following inges- patch tested with white soft paraffin, only 29 showed a positive tion of liquid paraffin. Intern Med 2002; 41: 483–6. dol; Balmed Hermal F; Balneum Hermal F†; Coliquifilm; Paragar; Woloderma†; Thai.: Balneum†; Duratears; Emulax; Oilatum Cream; Oila- 3. Karacan O, et al. Fire-eater’s pneumonia after aspiration of liq- reaction. White soft paraffin is generally less sensitising than yel- tum Plus; Turk.: Balmandol; UK: 50:50; Alpha Keri; Ashbourne Emollient low soft paraffin, although allergenicity differs from product to uid paraffin. Turk J Pediatr 2006; 48: 85–8. Medicinal Bath Oil†; Cetraben Emollient; Dermalo; Dermol; Diprobase; 4. Meltzer E, et al. Lipoid pneumonia: a preventable complication. Diprobath; Doublebase; Emollin; Emulsiderm; Epaderm; Hydromol; Imu- product. The allergenic components are probably polycyclic ar- Isr Med Assoc J 2006; 8: 33–5. derm; Infaderm; Lacri-Lube; Lubri-Tears; Mil-Par; Oilatum Cream; Oilatum omatic hydrocarbons present as impurities and quantities found Uses and Administration Emollient; Oilatum Junior; Oilatum Junior Flare-Up†; Oilatum Plus; Polytar in a particular paraffin depend on the source and purification Emollient; USA: Agoral; Akwa Tears; Alpha Keri; Bodi Care Lotion; Bodi Oil; method. Only the purest forms should be used in pharmaceuti- Taken orally, liquid paraffin acts as a lubricant and, since it keeps Desitin Creamy; Dry Eyes; Duratears Naturale; Geri-Silk; Haley’s M-O; He- the stools soft, it has been used in the symptomatic treatment of morid For Women; Hydrocerin; Hypotears; Lacri-Gel; Lacri-Lube; Lacti- cals, cosmetics, and for patch testing, and highly purified white constipation (p.1693), although it should be used with caution care; LubriFresh PM; LubriTears; Paladin; Puralube; Refresh PM; Soothe XP; soft paraffin is preferred to yellow soft paraffin. Stye; Tears Again; Tears Renewed; Throat Discs; Vagisil; Venez.: Agarol†; 1. Dooms-Goossens A, Degreef H. Contact allergy to petrolatums because of its adverse effects. The recommended daily oral dose Lacrimart†; Mil-Par; Milcor†; Oleoderm. is 10 to 30 mL in divided doses, preferably before breakfast and (I). Sensitising capacity of different brands of yellow and white at night. An emulsion of liquid paraffin may also be used in a petrolatums. Contact Dermatitis 1983; 9: 175–85. 2. Dooms-Goossens A, Degreef H. Contact allergy to petrolatums dose of 10 to 30 mL at night. Liquid paraffin and its preparations (II). Attempts to identify the nature of the allergens. Contact should not, however, be taken immediately before going to bed. White Soft Paraffin Dermatitis 1983; 9: 247–56. Liquid paraffin is an ingredient of several preparations that con- 905 (mineral hydrocarbons); Minkštasis baltas parafinas; Paraff. 3. Dooms-Goossens A, Dooms M. Contact allergy to petrolatums tain other laxatives such as cascara, magnesium hydroxide, or Moll. Alb.; Paraffinum Molle Album; Parafina blanda blanca; Valk- (III). Allergenicity prediction and pharmacopoeial requirements. Contact Dermatitis 1983; 9: 352–9. phenolphthalein. It has also been given as an enema in a usual ovaseliini; Vaselin, vitt; Vaselina blanca; Vaselina Branca; Vaselina dose of 120 mL. 4. Schnuch A, et al. White petrolatum (Ph. Eur.) is virtually non- filante; Vaseline blanche; Vaseline Officinale; Vaselinum album; Va- sensitizing: analysis of IVDK data on 80 000 patients tested be- Externally, liquid paraffin may be used as an ingredient of oint- zelína bílá; Wazelina biała; White Petrolatum; White Petroleum tween 1992 and 2004 and short discussion of identification and ment bases, as an emollient and cleanser in certain skin condi- Jelly. designation of allergens. Contact Dermatitis 2006; 54: 338–43. tions, and as an ophthalmic lubricant in the management of dry eye (p.2140). Белый Вазелин Lipoid pneumonia. Various uses of soft paraffin have been as- sociated with lipoid pneumonia, including topical facial use to Pharmacopoeias. In Chin., Eur. (see p.vii), Int., Jpn, US, and Light liquid paraffin has similar uses to liquid paraffin. treat psoriasis,1 long-term intranasal application for a dry nose,2 Viet. and use as a lubricant during nasogastric intubation.3 Administration in children. UK licensed product informa- Many pharmacopoeias use the title Vaselinum Album; in some tion gives the following oral doses of liquid paraffin for consti- countries the name ‘Vaseline’ is a trade-mark. 1. Cohen MA, et al. Exogenous lipoid pneumonia caused by facial application of petrolatum. J Am Acad Dermatol 2003; 49: pation in children, to be taken at night: Ph. Eur. 6.2 (Paraffin, White Soft). Purified and wholly or nearly • under 3 years: not recommended 1128–30. decolorised mixture of semi-solid hydrocarbons, obtained from 2. Brown AC, et al. Exogenous lipoid pneumonia due to nasal ap- • 3 to 5 years: 2.5 to 5 mL petroleum. It may contain a suitable antoxidant. It is not suitable plication of petroleum jelly. Chest 1994; 105: 968–9. • 5 to 12 years: 5 to 10 mL for oral use. A white or almost white, translucent, soft unctuous 3. Bernabeu Mora R, et al. Neumonía lipoidea aguda debiba a la • over 12 years: as for adults mass, slightly fluorescent in daylight when melted. Drop point aspiratión accidental de vaselina utilizada en un sondaje na- sogástrico. Arch Bronconeumol 2000; 36: 485–7. For light liquid paraffin, the BNFC recommends a daily oral dose 35° to 70°. Practically insoluble in water, in alcohol, and in glyc- of 0.5 to 1 mL/kg, up to a maximum of 45 mL, for children aged erol; slightly soluble in dichloromethane. Protect from light. Uses and Administration 3 to 18 years. It should be taken after the evening meal but not The BP 2008 gives White Petroleum Jelly as an approved syno- Soft paraffin is used as an ointment basis and as an emollient in immediately before going to bed, and may be mixed with ice- nym. the management of skin disorders. It is not readily absorbed by cream or yogurt to improve palatability. USP 31 (White Petrolatum). A purified mixture of semisolid the skin. Sterile dressings containing soft paraffin are used for hydrocarbons obtained from petroleum, and wholly or nearly The BNFC gives the following oral doses of liquid paraffin wound dressing and as a packing material. Soft paraffin is also decolorised. It may contain a suitable stabiliser. A white or faint- emulsion, to be taken once daily but not immediately before go- included in ointments used as ophthalmic lubricants in the man- ly yellowish unctuous mass, transparent in thin layers even after ing to bed: agement of dry eye (p.2140). Application of soft paraffin has cooling to 0°. Insoluble in water; slightly soluble in cold or hot been used for the eradication of pubic lice from the eyelashes • under 3 years: not recommended alcohol and in cold dehydrated alcohol; freely soluble in chloro- (see Pediculosis, p.2034). It has been used as a contact medium • 3 to 12 years: 0.5 to 1 mL/kg, up to a maximum of 30 mL form, in benzene, and in carbon disulfide; soluble in ether, in to reduce pain during extracorporeal shock wave lithotripsy. Soft • 12 to 18 years: as for adults petroleum spirit, and in most fixed and volatile oils. paraffin is also used in food manufacturing. The symbol † denotes a preparation no longer actively marketed The symbol ⊗ denotes a substance whose use may be restricted in certain sports (see p.vii)