MIRACLE OF ALOE RUB ROLL ON - menthol liquid 
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  2.0 %

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 3 years and older ; apply to affected area no more than 3 to 4 times daily
             
                 under 3 years: ask a doctor

Inactive Ingredients : water , isopropyl alcohol , aloe barbadensis leaf juice , hydroxyethylcellulose , chamomilla recutita (matricaria) flower , eucalyptus globulus leaf oil , polysorbate 80 , fragrance , methylparaben , dmdm hydantoin

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

 Image of Label

MIRACLE OF ALOE RUB ROLL ON 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66391-0046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1.8 mL  in 90 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
CHAMOMILE (UNII: FGL3685T2X)  
CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
methylparaben (UNII: A2I8C7HI9T)  
dmdm hydantoin (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66391-0046-090 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/17/2006
Labeler - Winning Solutions (962718300)
Registrant - Beautymanufacturing Solutions Corperation (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beautymanufacturing Solutions Corperation783200723manufacture

Revised: 4/2011
Document Id: 0d2db50d-5660-4d9d-af2a-f2ec0a2cc900
Set id: 70a304d9-755b-40a2-a48e-491c8355410c
Version: 1
Effective Time: 20110404
 
Winning Solutions