Label: OARS AND ALPS MUSCLE RECOVERY BALM- menthol, methyl salicylate cream

  • NDC Code(s): 52261-6300-1
  • Packager: Cosco International, Inc
  • 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 14, 2022

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  • DRUG FACTS

    Menthol - 5%....................................External Analgesic
    Methyl Salicylate (NSAID) – 10%.........External Analgesic

  • Uses:

    For temporary relief of minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation

  • Warnings:

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DO NOT USE

    Do not use on wounds or damaged skin, with a heating pad, on a child under 12 years of age with arthritis-like condition.

  • ASK DOCTOR

    Ask a doctor before use if you have redness over the affected area.

    If pregnant or breast-feeding, or if you have sensitive skin, ask your doctor before use

    Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • INDICATIONS & USAGE

    When using this product avoid contact with eyes or mucous membranes, do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if: condition worsens or symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation occurs

  • Directions:

    Use only as directed. Apply generously and massage to affected area as needed. Do not use more than 3 to 4 times per day.
    Children under 12 years of age: ask a doctor before use.

  • Inactive Ingredients:

    Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Carbomer, Cetostearyl Alcohol, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexylglycerin, Octyl Palmitate, Fragrance, Glucosamine, Glyceryl Monostearate, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Turmeric Oil, Water

  • Other Information:

    Store at room temperature 68°F to 77°F (20° to 25°C)
    Do not expose to excessive heat

  • Questions or comments?

    Contact Hi@oarsandalps.com

  • Allergy Alert:

    Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.

  • PRINCIPAL DISPLAY PANEL

    3oz label

  • INGREDIENTS AND APPEARANCE
    OARS AND ALPS MUSCLE RECOVERY BALM 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-6300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 kg  in 1 kg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.1 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    OCTYL PALMITATE (UNII: UYY8LE6Q5Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-6300-10.085 kg in 1 TUBE; Type 0: Not a Combination Product02/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/14/2022
    Labeler - Cosco International, Inc (016433141)
    Registrant - Cosco International, Inc (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc016433141manufacture(52261-6300) , label(52261-6300) , pack(52261-6300)
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