Amazon Basics Cold & Hot Medicated Patch

Amazon Basics Cold & Hot Medicated Patch
SPL v5
SPL
SPL Set ID e3b4db12-c846-b984-e053-2a95a90a8e9a
Route
TOPICAL
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Phenoxyethanol Water Polyacrylic Acid (8000 Mw) Petrolatum Carboxymethylcellulose Sodium, Unspecified Form Povidone Polyethylene Glycol 400 Iodopropynyl Butylcarbamate Kaolin Polysorbate 80 Ethylhexylglycerin Dihydroxyaluminum Aminoacetate Titanium Dioxide Glycerin Sodium Polyacrylate (8000 Mw) Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Use

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Warnings

For external use only

Directions

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one 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.

Active Ingredient

Menthol 5%

Other Information

Store at room temperature, not to exceed 86'F (30'C).

Inactive Ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, glycerin, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

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.

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.

Stop Use and Consult 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.

Amazon Basics Cold & Hot Medicated Patch


Structured Label Content

Use

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one 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.

Active Ingredient

Menthol 5%

Other Information

Store at room temperature, not to exceed 86'F (30'C).

Inactive Ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, glycerin, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

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.

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.

Stop Use and Consult A Doctor If (Stop use and consult 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.

Amazon Basics Cold & Hot Medicated Patch


Advanced Ingredient Data


Raw Label Data

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