Capsaicin Heat Patch
FDA Label NDC 52000-040

10 label sections · Submitted to the FDA by Universal Distribution Center Llc · 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 drug facts, active ingredient, purpose, uses, warnings:, otc - 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 Ingredient

Capsicum Extract Capsaicin 0.025%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:
• Simple Backache  • Arthritis  • Strains  • Bruises  • Sprains

Warnings:

EXTERNAL USE ONLY

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

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

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 few days

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

Otc - Keep Out Of Reach Of Children

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 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 Information

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

Inactive Ingredients

camphor, eucalyptus oil, lanolin, peppermint oil, menthol, methyl salicylate, styrene/isoprene copolymer, zinc oxide

Packaging

Capsaicin Heat (52000040 2)

Capsaicin Heat (52000040 2)

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