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.

----------

WINNING SOLUTIONS - MIRACLE RUB (66391-1603)

Active Ingredient : Menthol 2.5%

                          Methylsalieylate 10.0%

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 Poison 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

Uses: Temporarly relieves minor aches and pains of muscles and joints due to

aloe barabardensis leaf Juice, water, stearic acid, cetyl alcohol, glyceryl stearate, PEG-100 stearte, petrolatum, dimethicone, triethanolamine, eucalyptus globulus leaf oil, imidazolidinyl urea, methylparaben, propylparaben

01b LBL_Miracle Rub 4z Rub 0314 OL

MIRACLE RUB 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66391-1603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 106 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 106 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MANGO (UNII: I629I3NR86)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66391-1603-4112 g in 1 TUBE; Type 0: Not a Combination Product10/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/31/2016
Labeler - Winning Solutions (962718300)
Registrant - Winning Solutions (962718300)

Revised: 1/2023
Document Id: f21981f8-2b21-361a-e053-2a95a90a1856
Set id: 83132a51-cd28-40ff-ac70-95ea71df3752
Version: 4
Effective Time: 20230112
 
Winning Solutions