Leader Capsaicin Hot Patches

Leader Capsaicin Hot Patches
SPL v6
SPL
SPL Set ID 76e6bc39-643c-4264-8d98-0e4fa7d778e2
Route
TOPICAL
Published
Effective Date 2020-06-01
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 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 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

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

Questions

TOLL-FREE

Customer Care Help Line

866-326-1313

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017



Made in China

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)

Purpose

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

muschle sprains, bruises

Questions (QUESTIONS)

TOLL-FREE

Customer Care Help Line

866-326-1313

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017



Made in China

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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