Label: NATURAL 17 MUSCLE- camphor 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 November 9, 2022

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  • ACTIVE INGREDIENT

    Camphor …………………….……………….………….………0.33 %

  • PURPOSE

    External Analgesic

  • USES:

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

  • WARNINGS

    For external use only.
    Avoid contact with eyes or mucous membrane.
    Do not apply to wounds or damaged skin
    Do not bandage tightly or use with a heating pad

    If symptoms persist for more than seven days, discontinue use and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

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

    Emergency Number: 1-800-222-1222

  • PREGNANCY OR BREAST FEEDING

    Ask a health professional before use.

  • DIRECTIONS:

    Adults and children two-years of age or older:

    Apply to affected area not more than three to four times daily.

    Children under two-years of age: consult a physician.

  • Additional Information:

    Store at room temperature.

  • INACTIVE INGREDIENT

    Aqua, Carbomer, Propylene Glycol, Methylparaben, DMDM Hydantoin, Isopropyl Alcohol, Polysorbate 20, Oleth-20, Sodium Hydroxide, Eucalyptus Globulus Leaf Oil, Menthol, Mentha Piperita (Peppermint) Oil, FD&C Blue #1 (CI 42090).

  • PRINCIPAL DISPLAY PANEL

    MUSCLE GEL 4OZ

  • INGREDIENTS AND APPEARANCE
    NATURAL 17 MUSCLE 
    camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80770-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.33 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    BASIC BLUE 1 (UNII: 92N74OA24D)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    OLETH-20 (UNII: YTH167I2AG)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80770-033-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/03/2020
    Labeler - NATURAL 17 (103497833)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(80770-033)
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