Capsaicin Heat Patch
FDA Label NDC 52000-040

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 Capsaicin Heat (NDC 52000-040). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Capsicum Extract Capsaicin 0.025%

Otc - Purpose

Purpose

Topical Analgesic

Indications & Usage

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:

  • Simple Backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

Warnings

External use only.

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • with, or at the same times as other external analgesic
  • if you are allergic to any ingredients of this product

Otc - When Using

When using this product

  • do not use otherwise than as directed.
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Otc - Stop Use

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

Directions

Adults and Children 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area not more than 3 to 4 times daily
  • Remove patch from skin after at most 8 hours of application

    • Children under 12 years of age: Consult a doctor.

Other

Other information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredient

Inactive Ingredients

lanolin, methyl salicylate, natural latex rubber, peppermint oil, petrolatum, rosin, zinc oxide

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

Capsaicin Heat Patch

Label (Capsaicin Heat Patch)

Label (Capsaicin Heat Patch)

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