Cold Hot Medicated Patch 5% Menthol

Cold Hot Medicated Patch 5% Menthol
SPL v3
SPL
SPL Set ID 2d04799f-946d-ac53-e063-6294a90afeb7
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Isopropyl Myristate Polyvinyl Alcohol Water Glycerin Edetate Disodium Dihydroxyaluminum Aminoacetate Sorbitol Sorbitan Monooleate Titanium Dioxide Kaolin Polysorbate 80 Propylene Glycol Carboxymethylcellulose Sodium, Unspecified Form Tartaric Acid Methylparaben Polyacrylic Acid (8000 Mw) Sodium Polyacrylate (2500000 Mw) Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Active Ingredient ...............................................................................................Purpose Menthol 5%...............................................................................................Topical Analgesic

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Active Ingredient ...............................................................................................Purpose Menthol 5%...............................................................................................Topical Analgesic

Section 51945-4

Warnings

For External Use Only.

Active Ingredient

Active Ingredient ...............................................................................................Purpose



Menthol 5%...............................................................................................Topical Analgesic

Inactive Ingredient

dihydroxyaluminium aminoacetate, disodium EDTA, gelatin, glycerin, isopropyl myristate, methyl paraben, polysorbate 80, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, sorbitan monoleate 80, sorbitol, tartaric ac d, titanium dioxide, urea, water.

Indications & Usage

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis



■ muscle strains ■ muscle sprains ■ bruises ■ cramps

Dosage & Administration

Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

Children under 12 years of age: consult a physician.

When Using This Product

When using this product

■ Use only as directed

■ Rare cases of serious burns have been reported with products of this type

■Don't bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes

■ Don't apply to wounds or damaged skin

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

Stop Use and Ask A Doctor

If condition worsens ■ If redness is present ■ If irritation develops■ If symptoms persist for more than 7 days or clear up and occur again within a few days.■ You experience signs injury, such a s pain, swelling, or blistering where the product was applied.

If Pregnant Or Breastfeeding

ask a health professional before use.

Keep Out of Reach of Children

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away


Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Topical Analgesic

Warnings (WARNINGS)

For External Use Only.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient ...............................................................................................Purpose



Menthol 5%...............................................................................................Topical Analgesic

Inactive Ingredient (INACTIVE INGREDIENT)

dihydroxyaluminium aminoacetate, disodium EDTA, gelatin, glycerin, isopropyl myristate, methyl paraben, polysorbate 80, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, sorbitan monoleate 80, sorbitol, tartaric ac d, titanium dioxide, urea, water.

Indications & Usage (INDICATIONS & USAGE)

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis



■ muscle strains ■ muscle sprains ■ bruises ■ cramps

Dosage & Administration (DOSAGE & ADMINISTRATION)

Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

Children under 12 years of age: consult a physician.

When Using This Product (When using this product)

When using this product

■ Use only as directed

■ Rare cases of serious burns have been reported with products of this type

■Don't bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes

■ Don't apply to wounds or damaged skin

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If condition worsens ■ If redness is present ■ If irritation develops■ If symptoms persist for more than 7 days or clear up and occur again within a few days.■ You experience signs injury, such a s pain, swelling, or blistering where the product was applied.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

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

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away


Advanced Ingredient Data


Raw Label Data

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