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.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
-
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:
- IF PREGNANT OR BREAST – FEEDING:
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS:
- OTHER SAFETY INFORMATION
-
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 PAIN RELIEF CREAM 4 oz
- SUNSET - HEATING PAIN RELIEF CREAM 8 oz
- SUNSET - HEATING PAIN RELIEF CREAM 16 oz
-
INGREDIENTS AND APPEARANCE
HEATING PAIN RELIEF
methyl salicylate, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72937-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 9.8 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 17.6 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Color orange Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72937-180-02 60 mL in 1 JAR; Type 0: Not a Combination Product 09/15/2023 2 NDC:72937-180-04 118 mL in 1 JAR; Type 0: Not a Combination Product 09/15/2023 3 NDC:72937-180-08 237 mL in 1 JAR; Type 0: Not a Combination Product 09/15/2023 4 NDC:72937-180-16 473 mL in 1 JAR; Type 0: Not a Combination Product 09/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/15/2023 Labeler - SUNSET NOVELTIES, INC (067218145)