Heat Patch

Heat Patch
SPL v1
SPL
SPL Set ID 1a923e3b-ca0a-4a07-ba1a-76a4eb73598f
Route
TOPICAL
Published
Effective Date 2017-06-20
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

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-06-01

Description

Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming. 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.


Medication Information

Purpose

Temporary relief of minor pain.

Description

Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming. 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 associated with:

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

DIST. BY

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

Made in China

Questions

Customer Care Help Line

248-449-9300

www.qualitychoice.com

Do Not Use:
  • On areas with sensitive skin, open wounds or previous burns
  • with pain rubs, medicated lotions, creams or oinments
  • with other forms of heat theraphy, including heating pads, or multiples of this treatment on a single treatement site
Storage and Care:
  • One time use only; do not attempt to reuse the product
  • avoid storage in direct sunlight
  • Protect patch from excessive moisture
Active Ingredients

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

Directions for Use:

For Use on Adults and Childrens 12 Years of Age or Older

  • Clean and dru affected area; ensure area is fully dry before application
  • Remove patch from film
  • Apply to treatement site
  • Patch may be trimmerd to best fit treatment site; trim patch before removing film
  • Wash hands after application
  • Discard after signle use
Caution:
  • Take care when using on elderly ot incapacited persons
  • Do not use more than 8 hours
  • Do not use the Capsaicin Heat Patch more than 3-4 times daily
  • Do not exceed 7 days of continue use

For External Use Only
  • Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming.
  • 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

Use Only As Directed:
  • Follow the below directions for use.
  • Avoid contact with eyes, mucus membrances or skin rashes.

Keep Out of Reach of Children

if swallowed, contact a poison control center immediately.

Stop Use Immediately and Seek Medical Attention If:
  • Rash, itching or excessive skin irritation develops
  • Conditions worsens
  • Symptons persist more than 7 days
  • Symptoms clear, and reoccur within a few days

Structured Label Content

Uses

Temporary relief of minor pain associated with:

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

DIST. BY

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

Made in China

Purpose

Temporary relief of minor pain.

Questions (QUESTIONS)

Customer Care Help Line

248-449-9300

www.qualitychoice.com

Do Not Use:
  • On areas with sensitive skin, open wounds or previous burns
  • with pain rubs, medicated lotions, creams or oinments
  • with other forms of heat theraphy, including heating pads, or multiples of this treatment on a single treatement site
Storage and Care:
  • One time use only; do not attempt to reuse the product
  • avoid storage in direct sunlight
  • Protect patch from excessive moisture
Active Ingredients

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

Directions for Use:

For Use on Adults and Childrens 12 Years of Age or Older

  • Clean and dru affected area; ensure area is fully dry before application
  • Remove patch from film
  • Apply to treatement site
  • Patch may be trimmerd to best fit treatment site; trim patch before removing film
  • Wash hands after application
  • Discard after signle use
Caution:
  • Take care when using on elderly ot incapacited persons
  • Do not use more than 8 hours
  • Do not use the Capsaicin Heat Patch more than 3-4 times daily
  • Do not exceed 7 days of continue use

For External Use Only
  • Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming.
  • 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

Use Only As Directed: (Use Only as Directed:)
  • Follow the below directions for use.
  • Avoid contact with eyes, mucus membrances or skin rashes.

Keep Out of Reach of Children

if swallowed, contact a poison control center immediately.

Stop Use Immediately and Seek Medical Attention If: (Stop Use immediately and Seek Medical Attention if:)
  • Rash, itching or excessive skin irritation develops
  • Conditions worsens
  • Symptons persist more than 7 days
  • Symptoms clear, and reoccur within a few days

Advanced Ingredient Data


Raw Label Data

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