SUNSET COOLING PAIN RELIEF ROLL-ON- menthol gel

SUNSET COOLING PAIN RELIEF ROLL-ON by

Drug Labeling and Warnings

SUNSET COOLING PAIN RELIEF ROLL-ON 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 ………………………………...…………………………….…. 4%

PURPOSE

Topical Analgesic

Use

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

WARNINGS

For external use only.

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

WHEN USING

Avoid contact with the eyes or mucous membranes.
Do not apply to wounds or damaged skin.
Do not apply to the irritated skin or if excessive irritation develops.
Do not bandage tightly.
Do not use with heating pad or device.
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

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 of age.

● 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.

Children under 12 years of age: Do not use, consult a doctor

Other information

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

INACTIVE INGREDIENT

Water (Aqua), Alcohol Denat, Ceteareth-25, Caprylic/Capric Triglyceride, Glycerin, Calendula Officinalis Extract, Cannabis Sativa Seed Oil, Carbomer, Sodium Hydroxide, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Blue No.1 (CI 42090).

Questions or comments?

Contact us +1 (888) 367-4916

SUNSET COOLING PAIN RELIEF ROLL-ON

INGREDIENTS AND APPEARANCE

SUNSET COOLING PAIN RELIEF ROLL-ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-631
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBIC ACID (UNII: X045WJ989B)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CETEARETH-25 (UNII: 8FA93U5T67)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALCOHOL (UNII: 3K9958V90M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-631-03	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/01/2025

Labeler - SUNSET NOVELTIES, INC (067218145)