Honest Med Capsaicin Patch
FDA Label NDC 84097-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proper Buys Llc for the product Honest Med Capsaicin Patch (NDC 84097-003). 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 ask a doctor:, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Capsaicin: 0.025%...........................Topical Analgesic

Purpose

Topical Analgesic

Uses

Temporary relief of minor pain of muscles and joints associated with:

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises

Warnings

For External use only

  • Allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili peppers, consult with your physician before use.

Do Not Use:

  • On wounds or damaged skin
  • with pain rubs, medicated lotions, creams or ointments
  • with a heating pad.

When Using This Product

■ use only as directed

■ avoid contact with 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

■ do not microwave

■ 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.

Stop Use And Ask A Doctor:

Stop use and ask a doctor if

■ skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur

■ condition worsens

■symptoms persist more than 7 days

■symptoms clear and reoccur within a few days.

Keep Out Of Reach Of Children

if swallowed, contact a poison control center (1-800-222-1222) right away.

Directions For Use:

Adults and Childrens 12 Years of Age or Over

  • Clean and dry affected area; free of lotions, ointments and creams
  • Carefully remove backing starting at a corner. Apply sticky side of patch to affected area
  • Do not use more than one patch in an 8-hour period. Repeat as necessary. Maximum 3 patches per day
  • Discard after signle use

    • Children under 12 years of age:

    • Consult a physician

Other Information

  • avoid storage in direct sunlight
  • Protect patch from excessive moisture

Inactive Ingredients:

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

Questions

call 1-833-933-2323

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