Theracare Medicated Pain Relief Patch
FDA Label NDC 71101-128

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 Theracare Medicated Pain Relief (NDC 71101-128). 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, purpose, uses, warnings, do not use, when using this product, stop use and consult a doctor, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

External Analgesic

Uses

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

Warnings

For external use only.

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do Not Use

Do not use ■ More than one patch on your body at a time ■On wounds or damaged skin ■With a heating pad ■If you are allergic to any ingredients of this product.

When Using This Product

When using this product■Use only as directed ■ Avoid contact with eyes, mucous membranes or rashes■Do not bandage tightly■Do not use at the same time as other topical analgesics■Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.

Stop Use And Consult A Doctor

Stop use and consult a doctor if■Rash, itching or excessive skin irritation develops ■Condition worsens■Symptoms last more than 7 days or clear up and occur again within a few days.

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 (1-800-222-1222) right away.

Directions

Directions

Adults and children 12 year.; of age and over: ■Clean and dry affected area, free of lotions, ointments and creams. Remove patch from film, apply to affected area. Do not use more than one patch in a 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

Children under 12 year.; of age: ■Consult a physician.

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene/Isoprene Copolymer

Questions

Call toll free 1-866-326-1313

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