Healthwise Capsaicin Heat Patch

Healthwise Capsaicin Heat Patch
SPL v1
SPL
SPL Set ID 150c1f09-8aa7-67ea-e063-6294a90a950a
Route
TOPICAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Hydrogenated Polydecene (550 Mw) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/acrylamide Copolymer (mw 500000)

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

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

Purpose

Temporary relief of minor pain associated with: arthritis, minor backache, muscle strains, muschle sprains, bruises


Medication Information

Purpose

Temporary relief of minor pain associated with: arthritis, minor backache, muscle strains,

muschle sprains, bruises

Description

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

Uses

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

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

Questions

call 1-866-326-1313

Do Not Use:
  • On wounds or damaged skin
  • with pain rubs, medicated lotions, creams or ointments
  • with a heating pad.
Other Information

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

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

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
For External Use Only

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



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) right away.


Structured Label Content

Uses

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

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

Purpose

Temporary relief of minor pain associated with: arthritis, minor backache, muscle strains,

muschle sprains, bruises

Questions (QUESTIONS)

call 1-866-326-1313

Do Not Use:
  • On wounds or damaged skin
  • with pain rubs, medicated lotions, creams or ointments
  • with a heating pad.
Other Information

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

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

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
For External Use Only

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

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.



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) right away.


Advanced Ingredient Data


Raw Label Data

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