Menthol Patch

Menthol Patch
SPL v1
SPL
SPL Set ID 30914c0a-fbda-5674-e063-6294a90aba5b
Route
TRANSDERMAL
Published
Effective Date 2025-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, (+)- (500 mg)
Inactive Ingredients
Arnica Montana Flower Camellia Sinensis Leaf Povidone K90 Petrolatum Hydroxyacetophenone Titanium Dioxide Propylene Glycol Glycerin Kaolin Tartaric Acid Sodium Polyacrylate (2500000 Mw) Dihydroxyaluminum Aminoacetate Anhydrous Methylparaben Edetate Disodium Polysorbate 80 Propylparaben Water Cellulose Gum Frankincense Mineral Oil Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-14

Description

Menthol 5%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Menthol 5%

Uses

Temporary relief from minor aches and pains of sore muscles and joints

associated with:

  • arthrits
  • backache
  • strains
  • sprains

Section 51945-4

Warnings

For external use only.

Questions?

Call toll-free: (307) 410-3813 or Email: [email protected]

Directions:

Adults and Children 12 Years of Age or Over: Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

Children Under 12 Years of Age: Consult physician.

Other Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sodium Polyacrylate, Titanium dioxide, Water

When Using This Product
  • Use only as directed
  • Do not bandage tightly or use with heating pad or device
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments,creams,sprays, or liniments
  • Do not apply to irritated skin
  • Store in a cool, dry place away from sunlight
Stop Use and Ask A Doctor If

Burning discomfort or excessive skin irritation develops, condition wrosens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Keep Out of the Reach of Children

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Active Ingredients (in Each Patch)

Menthol 5%

If You Are Pregnant Or Breast Feeding

IF YOU ARE PREGNANT OR BREAST-FEEDING: Consult with physician before use of this product.

Consult With A Doctor Or Pharmacist Before Continued Use If You Have

Sensitive Skin


Structured Label Content

Uses (USES)

Temporary relief from minor aches and pains of sore muscles and joints

associated with:

  • arthrits
  • backache
  • strains
  • sprains

Section 51945-4 (51945-4)

Purpose (PURPOSE)

External Analgesic

Warnings (WARNINGS)

For external use only.

Questions? (QUESTIONS?)

Call toll-free: (307) 410-3813 or Email: [email protected]

Directions: (DIRECTIONS:)

Adults and Children 12 Years of Age or Over: Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

Children Under 12 Years of Age: Consult physician.

Other Ingredients (OTHER INGREDIENTS)

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sodium Polyacrylate, Titanium dioxide, Water

When Using This Product (WHEN USING THIS PRODUCT)
  • Use only as directed
  • Do not bandage tightly or use with heating pad or device
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments,creams,sprays, or liniments
  • Do not apply to irritated skin
  • Store in a cool, dry place away from sunlight
Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

Burning discomfort or excessive skin irritation develops, condition wrosens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Keep Out of the Reach of Children (KEEP OUT OF THE REACH OF CHILDREN)

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Active Ingredients (in Each Patch) (ACTIVE INGREDIENTS (IN EACH PATCH))

Menthol 5%

If You Are Pregnant Or Breast Feeding (IF YOU ARE PREGNANT OR BREAST-FEEDING)

IF YOU ARE PREGNANT OR BREAST-FEEDING: Consult with physician before use of this product.

Consult With A Doctor Or Pharmacist Before Continued Use If You Have (CONSULT WITH A DOCTOR OR PHARMACIST BEFORE CONTINUED USE IF YOU HAVE)

Sensitive Skin


Advanced Ingredient Data


Raw Label Data

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