Label: MENTHOL, CAMPHOR cream

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

Drug Label Information

Updated March 12, 2024

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

  • ACTIVE INGREDIENT

    Menthol 3%

    Camphor 3%

  • PURPOSE

    External Analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only.
    Use only as directed.
    Do not bandage tightly.
    Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

    If prone to allergic reaction to the product, consult to a doctor before using.

  • ASK DOCTOR

    Ask a doctor before use if you have redness over affected area.

  • WHEN USING

    Avoid contact with eyes, mucous membranes, rashes.
    Do not apply to wounds or damaged skin.
    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.

    If rash, redness or itchiness results; discontinue use and consult a doctor.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast – feeding

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years of age

    Apply a thin layer to the affected area and rub gently not more than 3 to 4 times a day.
    Wash hands with soap and water after use.

    Children under 12 years of age; do not use unless directed by a doctor.

  • OTHER SAFETY INFORMATION

    Store at room temperature 15° - 30°C (59° - 86°F)

  • INACTIVE INGREDIENT

    Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Stearic Acid, Glycereth-26, Propylene Glycol, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Diazolidinyl Urea, Methylparaben, Propylparaben, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

  • COOL RELIEF CREAM

    cool relief cream

  • INGREDIENTS AND APPEARANCE
    MENTHOL, CAMPHOR 
    menthol, camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80465-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GERANIOL (UNII: L837108USY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    COMFREY (UNII: D05HXK6R3G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    AMINO ACIDS, WHEAT (UNII: 0370GZL32F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80465-003-04113 g in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/04/2020
    Labeler - EROS GLOBAL (117597821)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(80465-003)