SPL v4
SPL
SPL Set ID 2f991134-b127-1832-e063-6394a90aef55
Route
TOPICAL
Published
Effective Date 2025-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (5 g)
Inactive Ingredients
Water Polysorbate 80 Kaolin Sodium Polyacrylate (2500000 Mw) Carbomer Glycerin Dmdm Hydantoin Propylene Glycol Carboxymethylcellulose Sodium Edetate Disodium Dihydroxyaluminum Aminoacetate Anhydrous Povidone K90 Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00

Purpose

Topical anesthetic


Medication Information

Purpose
Dosage and Administration

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

apply 1 patch at a time to affected area, not more than 3 to 4 times daily

remove patch from the skin after at most 8-hour application



Children under 12 years of age: consult a doctor

Description

5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00

Uses

Temporarily relieves minor pains associated with:

arthritis

simple backache

bursitis

tendonitis

muscle strains

sprains

bruises

cramps

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Warnings (For external use only)

  • Do not use
  • more than 1 patch at a time
  • 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, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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.

Directions

Uses For temporary relieves minor pains associated with:

arthritis

simple backache

bursitis

tendonitis

muscle strains

sprains

bruises

cramps

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

apply 1 patch at a time to affected area, not more than 3 to 4 times daily

remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Active Ingredient
Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients
5% Menthol Pain Relief Patch, Package Ndc Code 85323 004 00

5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00


Structured Label Content

Uses

Temporarily relieves minor pains associated with:

arthritis

simple backache

bursitis

tendonitis

muscle strains

sprains

bruises

cramps

Dosage and Administration (34068-7)

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

apply 1 patch at a time to affected area, not more than 3 to 4 times daily

remove patch from the skin after at most 8-hour application



Children under 12 years of age: consult a doctor

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose
Warnings

Warnings (For external use only)

  • Do not use
  • more than 1 patch at a time
  • 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, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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.

Directions

Uses For temporary relieves minor pains associated with:

arthritis

simple backache

bursitis

tendonitis

muscle strains

sprains

bruises

cramps

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

apply 1 patch at a time to affected area, not more than 3 to 4 times daily

remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Active Ingredient
Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients
5% Menthol Pain Relief Patch, Package Ndc Code 85323 004 00 (5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00)

5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00


Advanced Ingredient Data


Raw Label Data

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