Label: ASPERFLEX- menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2023

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  • DRUG FACTS

  • Active Ingredient

    Menthol 10%

    Methyl Salicylate 15 %

  • Purpose

    External analgesic

  • Uses

    temporary relieves the minor aches and pain of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have

    redness over the affected area

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    adults and children 12 years of age and older:

    apply to affected area not more than 3 to 4 times daily

    children under 12 years of age: consult a doctor

  • Other Information

    store at 20°-25°C (68°-77°F).

    Close cap tightly after use.

  • Inactive ingredients

    citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified water, stearic acid, trolamine

  • Questions or Comments?

    Call toll-free 1-877-255-6999.

  • PRINCIPAL DISPLAY PANEL

    cream label

  • INGREDIENTS AND APPEARANCE
    ASPERFLEX 
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-6854
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-6854-385 g in 1 TUBE; Type 0: Not a Combination Product06/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/03/2024
    Labeler - Akron Pharma Inc. (067878881)
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