Capsaicin Patch

Capsaicin Patch
SPL v1
SPL
SPL Set ID 3bdcef94-d06f-9152-e063-6294a90a6072
Route
TRANSDERMAL
Published
Effective Date 2025-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (2.5 mg)
Inactive Ingredients
Kaolin Tartaric Acid Water Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Carboxymethylcellulose Sodium Polysorbate 80 Glycerin Edetate Disodium Povidone K90 Hydroxyacetophenone Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-08

Description

Capsaicin 0.025% w/w

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Capsaicin 0.025% w/w

Uses

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

  • simple backache
  • arthritis
  • stratins
  • bruises
  • sprains
Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

Do Not Use
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Drug Facts

Active Ingredient

Capsaicin 0.025% w/w

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

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Isopropyl Myristate, Polysorbate 80, PVP, Hydroxyacetophenone, Dihydroxyaluminum Aminoacetate, L-Tartaric Acid, Titanium Dioxide, Carboxymethylcellulose Sodium, Kaolin, Edetate Disodium.

Questions Or Comments

Call toll free (307) 410-3813 or [email protected]

When Using This Product
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
Stop Use and Ask A Doctor If
  • Rash, itching or excessive skin irratation develops
  • Condition worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding,

Ask a health professional before use

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 & pains of muscles & joints associated with:

  • simple backache
  • arthritis
  • stratins
  • bruises
  • sprains
Purpose

External analgesic

Warnings

For external use only

Directions

Adult and Children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour 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
  • If you are allergic to any ingredients of this product
Drug Facts

Active Ingredient

Capsaicin 0.025% w/w

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

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Isopropyl Myristate, Polysorbate 80, PVP, Hydroxyacetophenone, Dihydroxyaluminum Aminoacetate, L-Tartaric Acid, Titanium Dioxide, Carboxymethylcellulose Sodium, Kaolin, Edetate Disodium.

Questions Or Comments (Questions or Comments)

Call toll free (307) 410-3813 or [email protected]

When Using This Product (When using this product)
  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Rash, itching or excessive skin irratation develops
  • Condition worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again 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. (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

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