Cool Breeze Pain Relief Gel

Cool Breeze Pain Relief Gel
SPL v1
SPL
SPL Set ID 14dcf4ee-6778-49d4-8601-9205737432ea
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (51 mg)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Ethylhexylglycerin Isopropyl Alcohol Methyl Salicylate Phenoxyethanol Propylene Glycol Sodium Hydroxide Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-13
Description

Menthol 5.10%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 5.10%

Uses:
  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings:

For external use only

Do Not Use
  • on damaged or broken skin.
Drug Facts

Questions:

317-721-4699

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Menthol 5.10%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Methyl Salicylate, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, FD&C Blue #1, FD&C Yellow #5.

When Using This Product
  • Avoid contact with the eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
  • 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.

Structured Label Content

Uses:
  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.
Purpose

Topical Analgesic

Warnings:

For external use only

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Questions:

317-721-4699

Directions:
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Menthol 5.10%

Other Information: (Other information:)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Methyl Salicylate, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, FD&C Blue #1, FD&C Yellow #5.

When Using This Product (When using this product)
  • Avoid contact with the eyes.
  • Do not bandage tightly.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.701182 · Updated: 2026-03-14T23:01:49.492831