Theracare Pain Relief Patch
FDA Label NDC 71101-126

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 Pain Relief (NDC 71101-126). 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.

Label Section Quick Index

Purpose

External Analgesic

Uses

For temporary relief of pain.

Warnings

For external use only.

Do Not Use

■ over raw surfaces or blistered areas.

When Using This Product

■ avoid contact with the eyes

  • do not use more than one patch on your body at a time

Stop Use And Consult A Doctor

■ skin irritation develops

■ condition worsens

■ 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.

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

■Adults and children 12 years of age and overClean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 8 hour period.
Maximum 3 patches per day. Discard patch after single use.

■ Children under 12 years of age: Do not use, ask a doctor

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

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

Questions

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