Cvs Cooling Patch

Cvs Cooling Patch
SPL v2
SPL
SPL Set ID 42d97e29-f32d-a31b-e063-6394a90a88d8
Route
TOPICAL
Published
Effective Date 2025-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (0.5 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Tartaric Acid Camellia Sinensis Leaf Sodium Polyacrylate (8000 Mw) Pvp Water Aloe Barbadensis Leaf Juice Titanium Dioxide Glycerin Iodopropynyl Butylcarbamate Arnica Montana Flower Water Carboxymethylcellulose Sodium Petrolatum Kaolin Polyacrylic Acid (8000 Mw) Polysorbate 80 Diazolidinyl Urea Frankincense Mineral Oil Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-14

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

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

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
Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Active Ingredient

Menthol 5%

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.

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.

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)


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

Warnings

For external use only

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
Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Active Ingredient (Active ingredient)

Menthol 5%

Other Information (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 (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.

When Using 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 (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel Pouch Label (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)


Advanced Ingredient Data


Raw Label Data

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