Label: ANTIPHLAMINE- l-menthol, l-camphor, methyl salicylate patch

  • NDC Code(s): 73442-0010-1, 73442-0010-2
  • Packager: I World Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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 September 8, 2020

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  • ACTIVE INGREDIENT

    L-Menthol, L-Camphor, 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

  • DOSAGE & ADMINISTRATION

    For external use only

  • INACTIVE INGREDIENT

    acetone, chloroxylenol, water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIPHLAMINE 
    l-menthol, l-camphor, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73442-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-59 mg  in 1 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL8 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE46 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73442-0010-27 in 1 POUCH09/09/2020
    1NDC:73442-0010-11.433 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/09/2020
    Labeler - I World Pharmaceutical Co., Ltd. (688222857)
    Registrant - I World Pharmaceutical Co., Ltd. (688222857)
    Establishment
    NameAddressID/FEIBusiness Operations
    I World Pharmaceutical Co., Ltd.688222857manufacture(73442-0010)
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