MIRACLE RUB - menthol, methyl salicylate cream 
Winning Solutions

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.

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Active Ingredient : Menthol  , Methyl Salicylate


Purpose :  External Analgesic

Warnings : For external use only

Keep Out of Reach of Children :  In case of accidental ingestion , get medical help or contact a Position Control center right away.


Directions : adults and children 12 years and older ; apply to affected area no more than 3 to 4 times daily
             
                 under 12 years: ask a doctor before use

Inactive Ingredients : aloe barbadensis leaf juice , water , stearic acid , cetyl alcohol , glyceryl stearate (and) PEG-100 stearate , petrolatum , dimethicone, triethanolamine , eucalyptus globulus leaf oil ,  imidazolidinyl urea,  methylparaben , propylparaben

Uses : Temporarily relieves minor aches and pains of muscles and joints due to  * arthritis  * simple backache  * strains * sprains * bruises

 Image of Label

MIRACLE RUB 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66391-0603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.475 g  in 99 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE9.9 g  in 99 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66391-0603-099 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2005
Labeler - Winning Solutions (962718300)
Registrant - Beautymanufacturing Solutions Corperation (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beautymanufacturing Solutions Corperation783200723manufacture

Revised: 4/2011
Document Id: ea76436a-7eff-4d45-afdc-448b7399fc17
Set id: b23457b3-b45c-400f-b729-4b886a466368
Version: 1
Effective Time: 20110405
 
Winning Solutions