Label: HEATING PAIN RELIEF- methyl salicylate, menthol cream

  • NDC Code(s): 72937-180-02, 72937-180-04, 72937-180-08, 72937-180-16
  • 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 15, 2023

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

  • ACTIVE INGREDIENT

    Menthol 10%

    Methyl Salicylate 18%

  • PURPOSE

    Topical Analgesic.

  • USE

    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
    If you experience an allergic reaction, discontinue use and consult a doctor.

    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), Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD&C Yellow No.6 (CI 15985).

  • SUNSET - HEATING PAIN RELIEF CREAM 2 oz

    sunset heating 2

  • SUNSET - HEATING PAIN RELIEF CREAM 4 oz

    sunset heating 4

  • SUNSET - HEATING PAIN RELIEF CREAM 8 oz

    sunset heating 8

  • SUNSET - HEATING PAIN RELIEF CREAM 16 oz

    sunset heating 16

  • INGREDIENTS AND APPEARANCE
    HEATING PAIN RELIEF 
    methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.8 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE17.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    AMINO ACIDS, WHEAT (UNII: 0370GZL32F)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72937-180-0260 mL in 1 JAR; Type 0: Not a Combination Product09/15/2023
    2NDC:72937-180-04118 mL in 1 JAR; Type 0: Not a Combination Product09/15/2023
    3NDC:72937-180-08237 mL in 1 JAR; Type 0: Not a Combination Product09/15/2023
    4NDC:72937-180-16473 mL in 1 JAR; Type 0: Not a Combination Product09/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/15/2023
    Labeler - SUNSET NOVELTIES, INC (067218145)