9d9aa28f-d5d1-4854-b782-4324f684e133

SPL v1
SPL
SPL Set ID 9d9aa28f-d5d1-4854-b782-4324f684e133
Route
topical
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (4.26 g)
Inactive Ingredients
polysorbate 80 polyacrylic acid (450000 mw) polyvinyl alcohol, unspecified propylene glycol glycerin water dmdm hydantoin edetic acid sodium polyacrylate (8000 mw) dihydroxyaluminum aminoacetate isopropyl myristate tartaric acid titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-06

Purpose

Topical analgesic

Storage and Handling

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

Description

Menthol 4.26% w/w


Medication Information

Warnings

For external use only.

Purpose

Topical analgesic

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.

Storage and Handling

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

Inactive Ingredients

Glycerin, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Isopropyl myristate, Edetic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

Description

Menthol 4.26% w/w

Use

Temporary relief of minor pain.

Do Not Use

 On wounds, cuts, damaged or infected skin

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

Active Ingredient(s)

Menthol 4.26% w/w

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.

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only.

Purpose

Topical analgesic

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.

Storage and Handling (STORAGE AND HANDLING)

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

Inactive Ingredients (Inactive ingredients)

Glycerin, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Isopropyl myristate, Edetic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

Use

Temporary relief of minor pain.

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 4.26% w/w

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.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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