CVS COOLING PATCH- menthol patch

CVS Cooling Patch by

Drug Labeling and Warnings

CVS Cooling Patch by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Foshan Aqua Gel Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

Do not use

• on wounds or damaged skin
• with a heating pad
• if you are allergic to any ingredients of this product

When using this product

• use only as directed
• avoid contact with the eyes and mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritationd evelops
• do not bandage tightly or use with heating pad
• wash hands thoroughly after applying

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• redness is present
• irritation develops
• sympotoms persist for more than 10 days in the case of arthritis

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

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

Directions

• adults and children 12 years of age and older: clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain
• carefully remove the remaining film while pressing the patch firmly on the skin
• use on affected area not more than 3 to 4 times daily
• use one patch per application
• discard after use
• reseal pouch after opening to store unused patch
• children under 12 years of age: consult a physician
• wash hands after use with cool water

Other information

• store at room temperature, not to exceed 86°F (30°C)
• store in a cool dry place, away from direct sunlight

Inactive ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Cellulose Gum, Diazolidinyl Urea, Dihydroxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Principal Display Panel - Pouch Label

CVS Health®

Compare to the active ingredient in Biofreeze® Pain Relief Patch*

NDC: 51316-796-02

Large

Cooling Patch

Menthol 5.0%

Topical analgesic/Pain reliever

Temporarily relieves muscle & joint pain
Flexible adhesive patch
Single-use application

Designed to provide up to 8 hours of long-lasting pain relief†

2 Large Patches

3.94 in x 5.51 in (10 cm X 14 cm)

INGREDIENTS AND APPEARANCE

CVS COOLING PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-796
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.5 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TARTARIC ACID (UNII: W4888I119H)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PVP (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PETROLATUM (UNII: 4T6H12BN9U)
KAOLIN (UNII: 24H4NWX5CO)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FRANKINCENSE (UNII: R9XLF1R1WM)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-796-02	2 in 1 POUCH	11/14/2025
1		11 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/14/2025

Labeler - CVS Pharmacy (062312574)

Registrant - Foshan Aqua Gel Biotech Co., Ltd. (529128763)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	manufacture(51316-796)