Label: MENTHOLATUM- dl-menthol, methyl salicylate lotion

  • 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 November 28, 2018

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  • ACTIVE INGREDIENT

    DL-Menthol, Methyl Salicylate

  • PURPOSE

    ■ temporary relief aches and pains of muscles and joints associated with:

    • arthritis • simple backache

    • sprains • strains • bruises

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    ■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

    ■ children under 2 years of age: consult a doctor

  • WARNINGS

    Warnings

    For external use only.

    Flammable

    ■ Keep away from fire, flame, sparks and heated surfaces. Tight cap firmly.

    Stop use and ask a doctor if

    ■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days

    When using this product

    ■ Use only as direct

    ■ Avoid contact with eyes

    ■ Do not apply to wounds or damaged skin

    ■ Do not bandage tightly

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children

  • INACTIVE INGREDIENT

    acetone, chloroxylenol, water

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM 
    dl-menthol, methyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860) RACEMENTHOL60 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0014-175 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/15/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0014)
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