Label: MIRACLE RUB- menthol, methyl salicylate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 66391-0603-0 - Packager: Winning Solutions
- 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 April 5, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIRACLE RUB
menthol, methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66391-0603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.475 g in 99 g METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 9.9 g in 99 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) Dimethicone (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66391-0603-0 99 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/01/2005 Labeler - Winning Solutions (962718300) Registrant - Beautymanufacturing Solutions Corperation (783200723) Establishment Name Address ID/FEI Business Operations Beautymanufacturing Solutions Corperation 783200723 manufacture