Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID ec583129-55fc-4ab1-94e5-9c900b5d95ef
Route
TOPICAL
Published
Effective Date 2016-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (25 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Form Castor Oil Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Methylparaben Polyacrylic Acid (250000 Mw) Polysorbate 80 Polyvinyl Alcohol, Unspecified Propylene Glycol Caprylate Water Sodium Polyacrylate (8000 Mw) Sorbitol Talc Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-05

Description

Capsaicin 0.025%

Purpose

Capsaicin - Topical analgesic


Medication Information

Purpose

Capsaicin - Topical analgesic

Description

Capsaicin 0.025%

Uses

temporarily relieves minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains
Warnings

For external use only

  • use only as directed
  • do not use at least 1 hours before, or immediately after, a bath or shower
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad
Directions
  • adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
  • children under 12 years: ask a doctor
  • FOR BEST RESULTS: apply to clean, dry skin
  • tear open pouch and remove patch; if desired, cut patch to size
  • grasp both ends of the patch firmly with thumbs near center
  • stretch patch until the backing separates
  • remove protective film while applying patch directly to site of pain
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING
Active Ingredient

Capsaicin 0.025%

Inactive Ingredients

carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol monocaprylate, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, talc, tartaric acid

Questions Or Comments?

Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Principal Display Panel
Stop Use and Ask A Doctor If
  • condition worsens
  • excessive redness, irritation, burning or discomfort of the skin develops
  • symptoms persist for more than 7 days or 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.

Package/label Principal Display Panel


Structured Label Content

Uses

temporarily relieves minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains
Purpose

Capsaicin - Topical analgesic

Warnings

For external use only

  • use only as directed
  • do not use at least 1 hours before, or immediately after, a bath or shower
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad
Directions
  • adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
  • children under 12 years: ask a doctor
  • FOR BEST RESULTS: apply to clean, dry skin
  • tear open pouch and remove patch; if desired, cut patch to size
  • grasp both ends of the patch firmly with thumbs near center
  • stretch patch until the backing separates
  • remove protective film while applying patch directly to site of pain
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING
Active Ingredient (Active ingredient)

Capsaicin 0.025%

Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methylparaben, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, propylene glycol monocaprylate, purified water, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, talc, tartaric acid

Questions Or Comments? (Questions or comments?)

Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Principal Display Panel
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • excessive redness, irritation, burning or discomfort of the skin develops
  • symptoms persist for more than 7 days or 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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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