Drug Facts Camphor 3.5%
Total Page:16
File Type:pdf, Size:1020Kb
DR. OH BALM - camphor, capsaicin and menthol cream Ecometics, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Drug Facts Camphor 3.5% .. Topical Analgesic Menthol 1% .. Topical Analgesic Capsaicin 0.015% .. Topical Analgesic Benzyl Benzoate and Cymbopogon Nardus [ Citronella ] Oil and Citronellal and Citronellol . and Dodecanal and Geraniol and Eucalyptus Globulus Leaf Oil and Thymol and Phenoxybenzene Castor Oil Cetearyl Isononanoate and Ceteareth - 20 and Cetearyl Alcohol and Glyceryl Stearate and Glycerin . and Ceteareth - 2 and Cetyl Palmitate Hydroxyethyl Acrylate / Sodium Acryloyldimethyl Taurate Copolymer and Squalane [ plant origin ] and Polysorbate 60 Propylene Glycol and Diazolidinyl Urea and Mehtylparaben and Propylparaben Water NDC 17452-430-01 Dr. OH BALM (TM) Excellent for muscle and tendon pain made with essential oils Patents pending Information: www.drohbalm.com NET WT. 57g (2oz) For external use only Do not use on broken, damaged or irritated skin. Avoid contact with eyes or mucous membranes. Do not bandage. Stop use and consult a physician, if skin redness or excessive irritation develops or if pain last more than 7 days. For best results, refrain from strenuous activity while treating affected. Topical analgesic. Provides temporary relief of minor aches and pains. Apply generously and gently massage until Dr. OH BALM disappears. Apply no more than 3 times daily. Other Information: Store in a cool, dry location away from sunlight. Distributed by Dr. OH PATCH Inc. P.O. BOX 1646 LORTON, VA 22079 www.drohbalm.com Made in U.S.A. Keep out of reach of children Do not use on children under 12 years of age. If balm is swallowed, get medical help or contact a poison control center immediately. Apply generously and gently massage until Dr. OH BALM disappears. Apply no more than 3 times daily. DR. OH BALM camphor, capsaicin and menthol cream Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:17452-430 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL 1 g in 10 0 g CAMPHO R (SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) - CAMPHOR 3.5 g in 10 0 g UNII:5TJD8 2A1ET) (SYNTHETIC) 0 .0 15 g CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM) CAPSAICIN in 10 0 g Inactive Ingredients Ingredient Name Strength CASTO R O IL (UNII: D5340 Y2I9 G) BENZYL BENZO ATE (UNII: N8 6 3NB338 G) CITRO NELLA O IL (UNII: QYO8 Q0 6 7D0 ) CITRO NELLAL (UNII: QB9 9 VZZ7GZ) .BETA.-CITRO NELLO L, (R)- (UNII: P0 1OUT9 6 4K) LAURYL ALDEHYDE (UNII: C42O120 SEF) GERANIO L (UNII: L8 3710 8 USY) EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) THYMO L (UNII: 3J50 XA376 E) CETEARYL ISO NO NANO ATE (UNII: P5O0 1U9 9 NI) PO LYO XYL 2 0 CETO STEARYL ETHER (UNII: YRC528 SWUY) CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4) GLYCERIN (UNII: PDC6 A3C0 OX) CETYL PALMITATE (UNII: 5ZA2S6 B0 8 X) SQ UALANE (UNII: GW8 9 575KF9 ) PO LYSO RBATE 6 0 (UNII: CAL22UVI4M) PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8 C7HI9 T) PRO PYLPARABEN (UNII: Z8 IX2SC1OH) BENZO PHENO NE (UNII: 70 1M4TTV9 O) WATER (UNII: 0 59 QF0 KO0 R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17452-430 -0 1 57 g in 1 TUBE Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 0 4/23/20 12 Labeler - Ecometics, Inc. (064843923) Revised: 4/2012 Ecometics, Inc..