Label: MENTHOL, 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 December 7, 2022

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

  • ACTIVE INGREDIENT

    Menthol 6%

    Camphor 2%

  • PURPOSE

    Topical Analgesic

    Pain Relieving

  • USES:

    Aid for temporary local relief of minor pain in muscles or joints.

  • WARNINGS

    For external use only.

  • WHEN USING

    WHEN USING THIS PRODUCT:

    Use only as directed
    Do not bandage tightly or use with a heating pad
    Avoid contact with eyes and mucous membranes
    Do not apply to wounds or damaged, broken, or irritated skin
    A transient burning sensation or redness may occur upon application but generally disappears in several days
    If you experience an allergic reaction, discontinue use, and consult a physician
    Do not expose the area treated with product to heat or direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    Ask a health professional before use.

  • STOP USE

    Condition worsens
    Redness is present
    Irritation develops
    Symptoms persist for more than 7 days or clear up occur again within a few days

    You experience signs injury, such as pain, swelling or blistering where the product was applied.

  • DIRECTIONS:

    Adults and Children over 12 years:

    Apply a small amount on the area to be.
    Massaged in a circular motion until absorbed.
    Repeat as needed, but no more than 3 to 4 times per day.
    Store tightly closed in a dry place at room temperature between 59°-86° F (15°-30° C).

    Wash hands with soap and water after use.

  • INACTIVE INGREDIENT

    Aqua, Alcohol Denat, Propylene Glycol, Salicylic Acid, Glycerin, Polysorbate 20, Carbomer, Sodium Hydroxide, Mentha Arvensis Herb Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140).

  • GREEN FARM COOLING RELIEF GEL 1.7oz

    GREEN FARM COOLING RELIEF GEL 1.7

  • INGREDIENTS AND APPEARANCE
    MENTHOL, CAMPHOR 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 g
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Colorwhite (Turquoise) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72937-600-1748 g in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/22/2020
    Labeler - SUNSET NOVELTIES, INC (067218145)