MENTHOL, CAMPHOR by SUNSET NOVELTIES, INC MENTHOL, CAMPHOR gel

MENTHOL, CAMPHOR by

Drug Labeling and Warnings

MENTHOL, CAMPHOR 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 6%

Camphor 3%

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
• 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.

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 a circular motion until absorbed, let set for a few seconds.
• Repeat as needed, but no more than 3 to 4 times per day.
• Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
• Wash hands with soap and water after use.

Children under 12 years of age consult a doctor.

INACTIVE INGREDIENT

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

SUNSET - COOLING PAIN RELIEF GEL 4 Fl oz TUBE

SUNSET - COOLING PAIN RELIEF GEL 8 Fl oz TUBE

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-630
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
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)
THYMUS VULGARIS (THYME) OIL (UNII: 2UK410MY6B)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	turquoise	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-630-40	118 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2025
2	NDC: 72937-630-80	236 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2025

Labeler - SUNSET NOVELTIES, INC (067218145)