Label: MIRACLE RUB- menthol, methyl salicylate cream

  • 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 January 12, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient : Menthol 2.5%

                              Methylsalieylate 10.0%

  • PURPOSE

    Purpose : External Analgesic


  • WARNINGS

    Warnings: For external use only .

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children : In case of accidental ingestion, get medical help or contact a Poison Control center right away.


  • DOSAGE & ADMINISTRATION

    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

  • INDICATIONS & USAGE

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

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises

  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Miracle Rub 4z Rub 0314 OL

  • INGREDIENTS AND APPEARANCE
    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)
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