SPL v4
SPL
SPL Set ID 2f71193c-6e26-01c4-e063-6394a90a9631
Route
TOPICAL
Published
Effective Date 2025-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Kaolin Carbomer Edetate Disodium Propylene Glycol Polysorbate 80 Sodium Polyacrylate (2500000 Mw) Glycerin Dmdm Hydantoin Dihydroxyaluminum Aminoacetate Anhydrous Water Tartaric Acid Povidone K90 Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00

Purpose

Purpose: Topical anesthetic


Medication Information

Purpose

Purpose: Topical anesthetic

Dosage and Administration

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

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

Description

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Warnings (For external use only)

  • Do not use
  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of 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

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • 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.

Directions

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

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 apolication

Children under 12 years of age: consult a doctor

Active Ingredient

Active Ingredient: 0.025% Capsaicin

Other Information

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

Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.

0.025% Capsaicin Pain Relief Patch, Package Ndc Code: 85323 001 00

Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Purpose: Topical anesthetic

Warnings

Warnings (For external use only)

  • Do not use
  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of 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

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • 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.

Directions

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Adult and children 12 years of age and over:

clean and dry affected area

remove film from patch and apply to the skin (see illustration)

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 apolication

Children under 12 years of age: consult a doctor

Active Ingredient

Active Ingredient: 0.025% Capsaicin

Other Information (Other information)

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

Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.

0.025% Capsaicin Pain Relief Patch, Package Ndc Code: 85323 001 00 (0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00)

Advanced Ingredient Data


Raw Label Data

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