Thera Care Pain Relief Menthol Patchs Patch
FDA Label NDC 71101-913

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Thera Care Pain Relief Menthol Patchs (NDC 71101-913). 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 ingredient, inactive ingredient, keep out of reach of children, indications & usage, warnings, dosage & administration, purpose, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

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

Inactive Ingredient

dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control

Indications & Usage

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
■ muscle strains ■ muscle sprains ■ bruises ■ cramps

Warnings

For External Use Only.

Dosage & Administration

Adults and children over 12 years: 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 4 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

Purpose

Topical Analgesic

When Using This Product

Use only as directed ■ Don’t bandage tightly or use with heating pad
■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

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.

If Pregnant Or Breastfeeding

ask a health professional before use.

* Please review the disclaimer below.