27 CFR Ch. I (4–1–97 Edition)

§ 21.63 27 CFR Ch. I (4–1–97 Edition)

349. Miscellaneous drug processing (includ- 410. Disinfectants, insecticides, fungicides, ing manufacture of pills). and other biocides. 358. Processing miscellaneous chemicals. 430. Sterilizing and preserving solutions. 359. Processing miscellaneous products. 470. Theater sprays, incense, and room deodorants. (2) As a raw material: (2) Miscellaneous uses: 511. Vinegar. 512. Acetic acid. 812. Product development and pilot plant 521. Ethyl acetate. uses (own use only). 523. Other ethyl esters. 590. Synthetic resins. § 21.65 Formula No. 38–B. 910. Animal feed supplements. (a) Formula. To every 100 gallons of (3) Miscellaneous uses: alcohol add: 812. Product development and pilot plant Ten pounds of any one, or a total of 10 uses (own use only). pounds of two or more, of the oils and sub- stances listed below: § 21.63 Formula No. 36. Anethole, N.F. Anise oil, N.F. (a) Formula. To every 100 gallons of Bay oil (myrcia oil), N.F. XI. alcohol add: Benzaldehyde, N.F. Three gallons of ammonia, aqueous, 27 to Bergamot oil, N.F. XI. 30 percent by weight; 3 gallons of strong am- Bitter almond oil, N.F. X. monia solution, N.F.: 17.5 pounds of caustic Camphor, U.S.P. soda, liquid grade, containing 50 percent so- Cedar leaf oil, U.S.P. XIII. dium hydroxide by weight; or 12.0 pounds of Chlorothymol, N.F. XII. caustic soda, liquid grade, containing 73 per- Cinnamic aldehyde, N.F. IX. Cinnamon oil, N.F. cent sodium hydroxide by weight. Citronella oil, natural. (b) Authorized uses. (1) As a solvent: Clove oil, N.F. Coal tar, U.S.P. 141. Shampoos. Eucalyptol, N.F. XII. 142. Soap and bath preparations. Eucalyptus oil, N.F. 210. External pharmaceuticals, not U.S.P. Eugenol, U.S.P. or N.F. Guaiacol, N.F. X. 450. Cleaning solutions (including household Lavender oil, N.F. detergents). Menthol, U.S.P. (2) As a raw material: Methyl salicylate, N.F. Mustard oil, volatile (allyl isothiocyanate), 530. Ethylamines. U.S.P. XII. 540. Dyes and intermediates. Peppermint oil, N.F. 579. Other chemicals. Phenol, U.S.P. Phenyl salicylate (salol), N.F. XI. (3) Miscellaneous uses: Pine oil, N.F. XII. Pine needle oil, dwarf, N.F. 812. Product development and pilot plant Rosemary oil, N.F. XII. uses (own use only). Safrole. Sassafras oil, N.F. XI. § 21.64 Formula No. 37. Spearmint oil, N.F. (a) Formula. To every 100 gallons of Spearmint oil, terpeneless. alcohol add: Spike lavender oil, natural. Storax, U.S.P. Forty-five fluid onces of eucalyptol, N.F. Thyme oil, N.F. XII. XII, 30 avoirdupois ounces of thymol, N.F., Thymol, N.F. and 20 avoirdupois ounces of menthol, U.S.P. Tolu balsam, U.S.P. Turpentine oil, N.F. XI. (b) Authorized uses. (1) As a solvent: If it is shown that none of the above single 111. Hair and scalp preparations. denaturants or combinations can be used in 112. Bay rum. the manufacture of a particular product, the 113. Lotions and creams (hand, face, and user may submit an application to the Chief, body). Chemical Branch, requesting permission to 131. Dentifrices. use another essential oil or substance having 132. Mouth washes. denaturing properties satisfactory to the 210. External pharmaceuticals, not U.S.P. Chief, Chemical Branch. In such a case the or N.F. user shall furnish the Chief, Chemical 244. Antispetic solutions, U.S.P. or N.F. Branch, with specifications, assay methods,

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the name and address of the manufacturer, § 21.68 Formula No. 38–F. and an 8-ounce sample of the denaturant for analysis. (a) Formula. To every 100 gallons of alcohol add: (b) Authorized uses. (1) As a solvent: (1) Six pounds of either boric acid, N.F., or 111. Hair and scalp preparations. Polysorbate 80, N.F.; 11⁄3 pounds of thymol, 112. Bay rum. N.F.; 11⁄3 pounds of chlorothymol, N.F. XII; 113. Lotions and creams (hand, face, and and 11⁄3 pounds of menthol, U.S.P.; or body). (2) A total of at least 3 pounds of any two 114. Deodorants (body). or more denaturing materials listed under 121. Perfumes and perfume tinctures. Formula No. 38–B, plus sufficient boric acid, 122. Toilet waters and colognes. N.F., or Polysorbate 80, N.F., to total 10 131. Dentifrices. pounds of denaturant; or 132. Mouth washes. (3) Seven pounds of zinc chloride, U.S.P., 141. Shampoos. 2.6 fluid ounces of hydrochloric acid, N.F., 142. Soap and bath preparations. and a total of 3 pounds of any two or more of 210. External pharmaceuticals, not U.S.P. the denaturing materials listed under For- or N.F. mula No. 38–B. 243. Liniments, U.S.P. or N.F. (b) Authorized uses. (1) As a solvent: 244. Antiseptic solutions, U.S.P. or N.F. 249. Miscellaneous external pharma- 132. Mouth washes. ceuticals, U.S.P. or N.F. 210. External pharmaceuticals, not U.S.P. 349. Miscellaneous drug processing (includ- or N.F. ing manufacture of pills). 244. Antiseptic solutions, U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. (2) Miscellaneous uses: 430. Sterlizing and preserving solutions. 812. Product development and pilot plant 470. Theater sprays, incense, and room de- uses (own use only). odorants. (2) Miscellaneous uses: § 21.69 Formula No. 39. (a) Formula. To every 100 gallons of 812. Product development and pilot plant alcohol add: uses (own use only). Nine pounds of sodium salicylate, U.S.P., § 21.66 Formula No. 38–C. or salicylic acid, U.S.P.; 1.25 gallons of fluid 1 (a) Formula. To every 100 gallons of extract of quassia, N.F. VII; and ⁄8 gallon of tert-butyl alcohol. alcohol add: (b) Authorized uses. (1) As a solvent: Ten pounds of menthol, U.S.P., and 1.25 gallons of formaldehyde solution, U.S.P. 111. Hair and scalp preparations. 112. Bay rum. (b) Authorized uses. (1) As a solvent: 113. Lotions and creams (hand, face, and 131. Dentifrices. body). 132. Mouth washes. 121. Perfume and perfume tinctures. 122. Toilet waters and colognes. (2) Miscellaneous uses: (2) Miscellaneous uses: 812. Product development and pilot plant 812. Product development and pilot plant uses (own use only). uses (own use only).

§ 21.67 Formula No. 38–D. § 21.70 Formula No. 39–A. (a) Formula. To every 100 gallons of (a) Formula. To every 100 gallons of alcohol add: alcohol add: Two and one-half pounds of menthol, Sixty avoirdupois ounces of any one of the U.S.P., and 2.5 gallons of formaldehyde solu- following alkaloids or salts together with 1⁄8 tion, U.S.P. gallon of tert-butyl alcohol: (b) Authorized uses. (1) As a solvent: Quinine, N.F. X. Quinine bisulfate, N.F. XI. 131. Dentifrices. Quinine dihydrochloride, N.F. XI. 132. Mouth washes. Cinchonidine. Cinchonidine sulfate, N.F. IX. (2) Miscellaneous uses: (b) Authorized uses. (1) As a solvent: 812. Product development and pilot plant uses (own use only). 111. Hair and scalp preparations.

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