Pain Relief Hot Patch
FDA Label NDC 52000-046

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Pain Relief Hot Patch (NDC 52000-046). 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 drug facts, active ingredients (in each gram), purpose, uses, warnings:, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each Gram)

Menthol 30 mg

Capsaicin 0.83 mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

  • arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps

Warnings:

EXTERNAL USE ONLY

When using this product • use only as directed • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

STOP USE and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Adults and Children 12 years of age and older:

• Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions

• Apply to affected area not more than 3 to 4 times a daily

Children under 12 years of age: DO NOT use without consulting a doctor.

Other Information

• store at room temperature 68° to 77°F (20 to 25°C)

Inactive Ingredients

glycerin, sodium polyacrylate, aluminum glycinate, kaolin, methylparaben, propylparaben, alcohol, titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80, purified water

Packaging

Hotpatch (82634nwlb)

Hotpatch (82634nwlb)

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