Label: CAMPHOTROL- camphor, menthol gel

  • 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 January 19, 2022

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  • Active Ingredients (% by weight)

    Camphor 4%

    Menthol 10%

  • Purpose

    Analgesic (pain relief)

  • Uses

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

  • Warnings

    For external use only

    Do not use on

    ■ wounds ■ damaged skin

    When using this product

    ■ avoid getting into eyes or mucous membranes ■ do not bandage tightly

    Stop use and ask a doctor if

    ■ excessive irritation of the skin develops ■ condition worsens
    ■ symptoms last more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    ■ adults and children 12 years of age or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily 
    ■ children under the age of 12: do not use, consult a doctor ■ use only as directed

  • Other information

    ■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    Acrylates Copolymer, Alcohol Denat., Boswellia Serrata Extract, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Powder, Magnesium Chloride, Mentha Piperita (Peppermint) Oil, MSM (Methylsulfonylmethane), Propylene Glycol, Triethanolamine, Water.

  • Camphotrol®

    Label

  • INGREDIENTS AND APPEARANCE
    CAMPHOTROL 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-488
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    ALCOHOL (UNII: 3K9958V90M)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-488-0785 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/18/2022
    Labeler - PureTek Corporation (785961046)
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