Label: CAPASIL PAIN RELIEVING- 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 October 14, 2020

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  • Active ingredients


    Menthol 2.0%………... Topical Analgesic
    Methyl Salicylate 10%…Topical Analgesic

  • Purpose

    Topical Analgesic

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

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

  • Warnings

    For external use only.

    Do not

    • apply on wounds or damaged skin
    • bandage tightly

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • 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.

  • Inactive ingredients

    Aloe Barbadensis(Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Borago Officinalis Seed
    Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-alpha-tocopheryl
    acetate, Eucalyptus Globulus Leaf Oil, Fragrance, Fructose, Phenoxyethanol,
    Propylene Glycol, Squalane, Stearic Acid, Stearyl Alcohol, Sodium Hydroxide,
    Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil.

  • STORAGE AND HANDLING

    Store at controlled room temperature 20°-25°C (68°-77°F).

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    CAPASIL  PAIN RELIEVING
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-434
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENHADEN OIL (UNII: 1D8HWC57D0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-434-0559 mL in 1 JAR; Type 0: Not a Combination Product10/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/14/2020
    Labeler - PureTek Corporation (785961046)
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