Extra Strength Cold And Hot Menthol Patch
FDA Label NDC 11822-6513

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Extra Strength Cold And Hot Menthol Patch (NDC 11822-6513). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, uses, warnings, when using this product, stop use and consult a doctor, otc - pregnancy or breast feeding, keep out of reach of children and pets., dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

For external use only.

When Using This Product

■ use only as directed

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

■ Don't bandage tightly or use with a heating pad

■ Avoid contact with the 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 Consult A Doctor

■ 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Keep Out Of Reach Of Children And Pets.

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

Dosage And Administration

Directions Adults and children 12 years of age and over :

■ 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.

Other Safety Information

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

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-iodo-2-propynyl butylcarbamate

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