Label: PAIN RELIEVING FOOT- menthyl salicylate and menthol, unspecified form 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 February 24, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Menthol 10.0%Topical Analgesic
    Methyl Salicylate 15.0%Topical Analgesic
  • Uses

    • For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises and sprains.
  • Warnings

    For external use only.

    • Avoid contact with the eyes and mucous membranes.

    • Do not use with any other topical ointment, sprays, creams or liniments.
    • Do not use with heating pads or heating devices.

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    • If pregnant or nursing: Consult a physician.

    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 6 years of age: Consult a doctor.
    • Retain carton for full product information.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Dimethicone, Dimethyl Sulfone, Emu Oil, Fragrance, Glucosamine HCl, Panthenol, Phenoxyethanol, Polysorbate 20, Red 33, Sodium Chondroitin Sulfate, Sodium Hydroxide, Stearic Acid, Water, Zingiber Officinale (Ginger) Root Extract.

  • Questions?

    Call toll-free (877) 281-3001

  • SPL UNCLASSIFIED SECTION

    Distributed by Brandable® Inc.
    269 S. Beverly Dr., Suite 8,
    Beverly Hills, CA 90212

  • PRINCIPAL DISPLAY PANEL - 85 G Container Box

    FOOT
    RELIEF

    Good Foundation

    Pain Relieving Cream

    aloe vera + menthol
    cool heating rub for
    extra strength pain relief

    NET WT 3 OZ (85 G)

    PRINCIPAL DISPLAY PANEL - 85 G Container Box
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING FOOT 
    menthyl salicylate and menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72764-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (Salicylic Acid - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-750 mg  in 5 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM500 mg  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Emu Oil (UNII: 344821WD61)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Allantoin (UNII: 344S277G0Z)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    GINGER (UNII: C5529G5JPQ)  
    Panthenol (UNII: WV9CM0O67Z)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72764-004-011 in 1 BOX04/01/2020
    185 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34804/01/2020
    Labeler - Brandable (080414109)
    Registrant - Garcoa Laboratories (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries255106239MANUFACTURE(72764-004)
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