Label: AXE BRAND MEDICATED- menthol, camphor and methyl salicylate oil

  • NDC Code(s): 57538-003-01
  • Packager: LEUNG KAI FOOK MEDICAL CO PTE LTD
  • 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 13, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients
    Menthol 16%
    Camphor 5%
    Methyl salicylate 15%

  • PurposeExternal analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to
    simple backache
    arthritis
    strains
    bruises
    sprains

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use
    on wounds
    on irritated or damaged skin
    on the face
    otherwise than as directed

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if
    condition worsens
    symptoms persist for more than 7 days
    symptoms clear up and occur again within a few days
    excessive irritation of the skin develops
    nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

    when using for pain of arthritis
    pain persists for more than 10 days
    redness is present
    in conditions affecting children under 12 years of age

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 3 years of age and older: Apply a few drops then gently rub into the affected area not more than 3 to 4 times daily.
    Children under 3 years of age: Do not use, consult your doctor.
    Refer to the above warnings; use otherwise than as directed may be dangerous

  • STORAGE AND HANDLING

    Other information
    keep container tightly closed
    store at 15 to 30C (59 to 86F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Eucalyptus oil, lavender oil and mineral oil.

  • QUESTIONS

    Questions or comments? (888)221-3496 M-F 9am to 5pm
    you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    AXE BRAND MEDICATED OIL NDC-57538-003-1 1.89 fl oz (56mL)IMAGE OF CARTON 56ML

  • INGREDIENTS AND APPEARANCE
    AXE BRAND MEDICATED 
    menthol, camphor and methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57538-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57538-003-0156 mL in 1 PACKAGE; Type 0: Not a Combination Product04/13/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/13/2001
    Labeler - LEUNG KAI FOOK MEDICAL CO PTE LTD (595107004)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEUNG KAI FOOK MEDICAL CO PTE LTD595107004manufacture(57538-003)