Capsaicin Heat Patch Pain Relief Patch

Capsaicin Heat Patch Pain Relief Patch
SPL v2
SPL
SPL Set ID e5819a56-e06d-cac9-e053-2995a90ac3ce
Route
TOPICAL
Published
Effective Date 2022-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/isoprene/styrene Block Copolymer Hydrogenated C6-20 Polyolefin (100 Cst)

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-01

Description

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

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

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

Uses

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

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises
Label

Warnings

For External Use Only

Questions

866-326-1313 Monday - Friday 8:30 am -4:30 pm CST

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
  • use one patch for up to 8 hours
  • Discard after single use
  • Children under 12 years of age: consult a physician
Do Not Use:
  • On wounds or damaged skin
  • with pain rubs, medicated lotions, creams, or ointments
  • with heating pads
Allergy Alert

If you are allergic or suspect you are allergic to the ingredients of this product, including chill peppers, consult with your physician before use.

Other Information
  • Avoid storage in direct sunlight
  • Protect patch from excessive moisture
Active Ingredients

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

Inactive Ingredients

hydrogenated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Inactive Ingredients:

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

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 a manner that always keeps products 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 ingest this patch.

If Pregnant Or Breast Feeding

Ask a health professional before use

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:
  • Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • Conditions worsens
  • Symptoms persist more than 7 days
  • Symptoms clear, and reoccur within a few days

Structured Label Content

Uses

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

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises
Label (LABEL)

Purpose

Topical Analgesic

Warnings

For External Use Only

Questions (QUESTIONS)

866-326-1313 Monday - Friday 8:30 am -4:30 pm CST

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
  • use one patch for up to 8 hours
  • Discard after single use
  • Children under 12 years of age: consult a physician
Do Not Use:
  • On wounds or damaged skin
  • with pain rubs, medicated lotions, creams, or ointments
  • with heating pads
Allergy Alert (Allergy alert)

If you are allergic or suspect you are allergic to the ingredients of this product, including chill peppers, consult with your physician before use.

Other Information
  • Avoid storage in direct sunlight
  • Protect patch from excessive moisture
Active Ingredients

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

Inactive Ingredients

hydrogenated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Inactive Ingredients:

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

When Using This Product (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 a manner that always keeps products 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 ingest this patch.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If: (Stop Use and ask a doctor if:)
  • Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • Conditions worsens
  • Symptoms persist more than 7 days
  • Symptoms clear, and reoccur within a few days

Advanced Ingredient Data


Raw Label Data

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