SUNSET COOLING PAIN RELIEF by SUNSET NOVELTIES, INC 72937-260-08

Drug Details [pdf]

SUNSET COOLING PAIN RELIEF- menthol, camphor cream
SUNSET NOVELTIES, INC

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72937-260-08

Camphor 2%

Menthol 6%

Topical Analgesic

USE

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

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

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.

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.

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

Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Salicylic Acid, Glycerin, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140).

SUNSET - COOLING PAIN RELIEF GEL 8oz

COOLING CREAM

SUNSET COOLING PAIN RELIEF
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-260
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CARBOMER 940 (UNII: 4Q93RCW27E)
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)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)

Product Characteristics
Color	turquoise	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 72937-260-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2024	04/15/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/15/2024	04/15/2024

Labeler - SUNSET NOVELTIES, INC (067218145)

Revised: 11/2025

Document Id: 44139a86-fff3-baff-e063-6394a90a00b8

Set id: 155fe0ac-3306-0332-e063-6294a90ae8c2

Version: 2

Effective Time: 20251120