Label: MENTHOL, CAMPHOR cream

  • 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 June 28, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Menthol 3%

    Camphor 3%

  • PURPOSE

    Menthol 3%……………………...…………………. PURPOSE: External Analgesic

    Camphor 3% ...................................................... PURPOSE: Pain Relieving

  • INDICATIONS & USAGE

    Avoid contact with eyes, mucous membranes, rashes, wounds or damaged skin.
    Do not apply on nose and genital area.

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

  • DOSAGE & ADMINISTRATION

    * Adults and children over 12 years of age; apply a thin layer to 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 doctor/physician

  • WARNINGS

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. Package not child resistant.

    In case of accidental ingestion, contact doctor immediately. If prone to allergic reaction to the product, consult to a doctor before using.

  • INACTIVE INGREDIENT

    Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Parfum, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, FD&C Blue 1 Powder (CI 42090)

  • PRINCIPAL DISPLAY PANEL

    4oz

  • 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
    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)  
    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 not finalpart34811/04/2020
    Labeler - EROS GLOBAL (117597821)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(80465-003)