72937-181-02 72937-181-04 72937-181-08 72937-181-16 72937-181-40 72937-181-80

SUNSET PAIN RELIEF HEATING by

Drug Labeling and Warnings

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

Drug Details [pdf]

SUNSET PAIN RELIEF HEATING CAMPHOR AND AMINO ACIDS- methyl salicylate, menthol cream 
SUNSET NOVELTIES, INC

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.

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72937-181-02
72937-181-04
72937-181-08
72937-181-16
72937-181-40
72937-181-80

Methyl Salicylate 18%

Menthol 10%

Topical Analgesic.

USES:

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

For external use only.

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.

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

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

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.

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 necessary, but no more than 3 to 4 times daily.
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.

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 #6 (CI 15985).

SUNSET - PAIN RELIEF HEATING CREAM 2 oz

SUNSET - PAIN RELIEF HEATING CREAM 4 oz

SUNSET - PAIN RELIEF HEATING CREAM 8 oz

SUNSET - PAIN RELIEF HEATING CREAM 16 oz

SUNSET - PAIN RELIEF HEATING CREAM 4 oz TUBE

SUNSET - PAIN RELIEF HEATING CREAM 8 oz TUBE

SUNSET PAIN RELIEF HEATING  CAMPHOR AND AMINO ACIDS
methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-181
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: 72937-181-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2022
2	NDC: 72937-181-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2022
3	NDC: 72937-181-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2022
4	NDC: 72937-181-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2022
5	NDC: 72937-181-40	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/26/2023
6	NDC: 72937-181-80	236 mL in 1 TUBE; Type 0: Not a Combination Product	05/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/09/2022

Labeler - SUNSET NOVELTIES, INC (067218145)

Revised: 5/2023

Document Id: fc9e2a51-d270-fbff-e053-6294a90a2e41

34390-5

Set id: e83e872e-5297-ec10-e053-2a95a90a59c1

Version: 2

Effective Time: 20230526