Label: ROCK SAUCE- methyl salicylate, menthol, capsicum lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 59663-100-02 - Packager: Shine & Pretty (USA), Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated June 2, 2012
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- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
ROCK SAUCE
methyl salicylate, menthol, capsicum lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59663-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 20 mL in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mL in 100 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 0.05 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ARNICA MONTANA (UNII: O80TY208ZW) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER 934 (UNII: Z135WT9208) TROLAMINE (UNII: 9O3K93S3TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59663-100-02 240 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/02/2012 Labeler - Shine & Pretty (USA), Corp. (603528605)