Pure-aid Capsaicin Pain Relief Patch

Pure-aid Capsaicin Pain Relief Patch
SPL v3
SPL
SPL Set ID dce9db37-cd07-44d8-8881-f63a2191964f
Route
TOPICAL
Published
Effective Date 2012-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.702 mg)
Inactive Ingredients
Hydrogenated Polydecene (550 Mw) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-23

Description

Capsicum extract 0.025% as Capsaicin

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Capsicum extract 0.025% as Capsaicin

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache

  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.

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 for 7 days
  • Remove patch from the skin after at most 8 hour's application

Children under 12 years of age:

  • Consult a doctor



Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • with, or at the same times as other external analgesic products
  • if you are allergic to any ingredients of this product

Package Label

Capsaicin Hot Patch

Active Ingredient

Capsicum extract 0.025% as Capsaicin

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

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 the eyes, mucous membranes or rashes

Stop Use and Ask A Doctor If
  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache

  • arthritis
  • strains
  • bruises
  • sprains

Purpose

Topical analgesic

Warnings

For external use only.

Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.

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 for 7 days
  • Remove patch from the skin after at most 8 hour's application

Children under 12 years of age:

  • Consult a doctor



Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • with, or at the same times as other external analgesic products
  • if you are allergic to any ingredients of this product

Package Label (Package label)

Capsaicin Hot Patch

Active Ingredient (Active ingredient)

Capsicum extract 0.025% as Capsaicin

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients (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 the eyes, mucous membranes or rashes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)