Label: MENTHOL, CAMPHOR gel

  • NDC Code(s): 72937-006-02, 72937-006-04, 72937-006-08, 72937-006-16
  • Packager: SUNSET NOVELTIES, INC
  • 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 September 21, 2023

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

  • ACTIVE INGREDIENT

    Camphor 2%

    Menthol 6%

  • PURPOSE

    Topical Analgesic

  • USES:

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

  • WARNINGS

    For external use only. • Ask a doctor before use if you have redness over
    affected area.

  • WHEN USING

    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.

  • STOP USE AND ASK A DOCTOR IF:

    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.

  • IF PREGNANT OR BREAST – FEEDING:

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS:

    Adults and Children over 12 years
    • Apply a small amount on the affected area.• Massage in circular motion, let set for a
    few seconds.• Repeat as necessary, but no more than 3 to 4 times daily. • Wash hands
    with soap and water after use.
    Children under 12 years of age consult a doctor

  • OTHER SAFETY INFORMATION

    Store tightly closed in a dry place at controlled room temperature between 59°-86° F
    (15°-30° C).

  • INACTIVE INGREDIENT

    Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Salicylic Acid, Glycerin, Mentha Piperita (Peppermint) 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 No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).

  • SUNSET - COOLING PAIN RELIEF GEL 2oz

    SUNSET COOLING PAIN RELIEF 2

  • SUNSET - COOLING PAIN RELIEF GEL 4oz

    SUNSET COOLING PAIN RELIEF 4

  • SUNSET - COOLING PAIN RELIEF GEL 8oz

    SUNSET COOLING PAIN RELIEF 8

  • SUNSET - COOLING PAIN RELIEF GEL 16oz

    SUNSET COOLING PAIN RELIEF 16

  • INGREDIENTS AND APPEARANCE
    MENTHOL, CAMPHOR 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-006
    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
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    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)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYME OIL (UNII: 2UK410MY6B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    Product Characteristics
    Colorwhite (Turquoise) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72937-006-0259 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
    2NDC:72937-006-04118 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
    3NDC:72937-006-08236 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
    4NDC:72937-006-16472 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/22/2020
    Labeler - SUNSET NOVELTIES, INC (067218145)