Label: FAMILY CARE MUSCLE RUB PAIN RELIEVER- menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/14

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  • ACTIVE INGREDIENT

    Active ingredient                                                                                            Purpose

    Menthol- 10%, Methyl Salicylate- 15%............................................................External Analgesic

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  • PURPOSE

    Uses

    • For the temporary relief of minor aches and pains of muscles and joints
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  • WARNINGS

    Warnings

    For external use only. Use only as directed.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.

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  • DO NOT USE


    Discontinue use if excessive irritation of the skin develops. 

    Do not bandage tightly, apply to wounds or damaged skin or use with a heating pad.

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  • ASK DOCTOR

    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.

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  • WHEN USING

    Avoid contact with eyes or mucous membranes.

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  • INDICATIONS & USAGE

    Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Consult a doctor.
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  • STORAGE AND HANDLING

    Other information

    • Store at controlled room temperature 15-30 C (59-86 F)
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  • INACTIVE INGREDIENT

    Inactive ingredients

    Carbopol 940, Cetyl Alcohol, Oleth-3 Phosphate, Stearic Acid, Triethanolmine, Water

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  • DOSAGE & ADMINISTRATION

    Distributed by: UNITED EXCHANGE CORP. 17211 Valley View Ave, Cerritos, CA 90703 USA

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    FAMILY CARE MUSCLE RUB PAIN RELIEVER 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65923-498
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 10 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE C  
    CETYL ALCOHOL  
    OLETH-3 PHOSPHATE  
    STEARIC ACID  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-498-35 1 in 1 CARTON
    1 35 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/30/2012
    Labeler - UNITED EXCHANGE CORP (840130579)
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