SPL v1
SPL
SPL Set ID 3343d968-8fb1-c1aa-e063-6394a90a2ee3
Route
TOPICAL
Published
Effective Date 2024-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Polyvinyl Alcohol Propylene Glycol Edetic Acid Sodium Polyacrylate (8000 Mw) Polyacrylic Acid (800000 Mw) Isopropyl Myristate Titanium Dioxide Polyacrylic Acid (300000 Mw) Water Dmdm Hydantoin Dihydroxyaluminum Aminoacetate Tartaric Acid Glycerin Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-21

Description

Menthol 5% w/w.

Purpose

Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children


Medication Information

Purpose

Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children

Description

Menthol 5% w/w.

Use

Temporary relief of minor pain.

Section 51945-4

Warnings

For external use only.

Directions

For use by adults and children 12 years of age and older:

Carefully remove backing from patch

Apply sticky side of patch to affected area.

Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily.

Discard patch after single use.

Reseal pouch after opening.

Children under 12 years of age: consult a physician.

Do Not Use

On wounds, cuts, damaged or infected skin

On eyes, mouth, genitals, or any other mucous membranes

Active Ingredient(s)

Menthol 5% w/w.

Inactive Ingredients

Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetate Disodium Anhydrous, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Water

When Using This Product:

Use only as directed

Rear cases of serious burns have been reported with products of this type

Do not bandage tightly or use with a heating pad

Avoid contact with eyes and mucous membranes

Do not apply to wounds or damaged skin.

Do not use at the same time as other topical analgesics.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

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 breastfeeding, ask a health professional before use.


Structured Label Content

Use

Temporary relief of minor pain.

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only.

Directions

For use by adults and children 12 years of age and older:

Carefully remove backing from patch

Apply sticky side of patch to affected area.

Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily.

Discard patch after single use.

Reseal pouch after opening.

Children under 12 years of age: consult a physician.

Do Not Use (Do not use)

On wounds, cuts, damaged or infected skin

On eyes, mouth, genitals, or any other mucous membranes

Active Ingredient(s)

Menthol 5% w/w.

Inactive Ingredients (Inactive ingredients)

Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetate Disodium Anhydrous, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Water

Storage and Handling (STORAGE AND HANDLING)

Store between 15-30℃(59-86℉) keep away from children

When Using This Product: (When using this product:)

Use only as directed

Rear cases of serious burns have been reported with products of this type

Do not bandage tightly or use with a heating pad

Avoid contact with eyes and mucous membranes

Do not apply to wounds or damaged skin.

Do not use at the same time as other topical analgesics.

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

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Stop Use and Ask A Doctor If: (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 breastfeeding, ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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