HEATING PAIN RELIEF- methyl salicylate, menthol cream

HEATING PAIN RELIEF by

Drug Labeling and Warnings

HEATING PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by SUNSET NOVELTIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: do not use, 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 4 oz TUBE LIMITED EDITION

INGREDIENTS AND APPEARANCE

HEATING PAIN RELIEF 
methyl salicylate, menthol cream

Product 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 (Light Orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-180-42	118 mL in 1 TUBE; Type 0: Not a Combination Product	02/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/25/2023

Labeler - SUNSET NOVELTIES, INC (067218145)