CVS PAIN RELIEF- menthol 4% gel

CVS Pain Relief by

Drug Labeling and Warnings

CVS Pain Relief by is a Otc medication manufactured, distributed, or labeled by CVS, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 4%

PURPOSE

External Analgesic

INDICATIONS & USAGE

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains, bruises, and muscle strains.

WARNINGS

For external use only.

Flammable. Keep away from excessive heat or open flame.

When using this product use only as directed. Avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin, do no apply to irritated skin or if excessive irritation develops, do not bandage tightly or use with heating pad or device. Children 12 years of age and older: use only under adult supervision.

Stop use and ask a doctor if you experience pain, swelling, or blistering of the skin, condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Adults and children of 12 years: rub a thin film over affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. Wash hands after use with cool water.

INACTIVE INGREDIENT

Carbomer, fragrance, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS PAIN RELIEF 
menthol 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W)	MENTHOL, (+)-	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-161-02	74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/2024
2	NDC: 51316-161-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	11/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/15/2024

Labeler - CVS (062312574)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(51316-161)