Label: MENTHOL, CAMPHOR cream

  • 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 July 12, 2022

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

  • 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.

    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, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Parfum, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue #1 Powder (CI 42090).

  • INDICATIONS & USAGE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. Package not child resistant.

  • PURPOSE

    External Analgesic

    Pain Relieving

  • ACTIVE INGREDIENT

    Menthol 10%

    Camphor 3%

  • PRINCIPAL DISPLAY PANEL

    4oz

  • INGREDIENTS AND APPEARANCE
    MENTHOL, CAMPHOR 
    menthol, camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    TRIBUTYL CITRATE (UNII: 827D5B1B6S)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    BUTETH-3 (UNII: OC116GRO69)  
    BASIC BLUE 1 (UNII: 92N74OA24D)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72937-310-04113 g in 1 TUBE; Type 0: Not a Combination Product03/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/04/2021
    Labeler - SUNSET NOVELTIES, INC (067218145)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(72937-310)