85323-005, 0.025% Capsaicin Pain Relief Patch

85323-005, 0.025% Capsaicin Pain Relief Patch
SPL v3
SPL
SPL Set ID 37776daf-c8ff-167f-e063-6294a90aedbb
Route
TOPICAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Kaolin Carbomer 934 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 2025-06-10

Description

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-005-01

Purpose

Purpose: Topical anesthetic


Medication Information

Indications and Usage

For temporary relief of minor aches and 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 patch from film
  • Apply to affected area not more than 3 to 4 times daily
  • Remove patch from skin after at most 8 hours of application

Children under 12 years of age: consult a doctor.

Purpose

Purpose: Topical anesthetic

Description

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-005-01

Uses

For temporary relief of minor aches and 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 (1-800-222-1222) immediately.

Warnings

Warnings: For external use only

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • with or at the same times as other external analgesic
  • if you are allergic to any ingredients of this product

When using this product

  • do not use otherwise than as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within 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 (1-800-222-1222) immediately.

Directions

Adult 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
  • Remove patch from skin after at most 8 hours of application

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, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, Dmdm Hydantoin.

0.025% Capsaicin Pain Relief Patch, Package Ndc Code: 85323 005 01

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-005-01


Structured Label Content

Uses

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

  • Simple Backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
Indications and Usage (34067-9)

For temporary relief of minor aches and 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 patch from film
  • Apply to affected area not more than 3 to 4 times daily
  • Remove patch from skin after at most 8 hours of 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 (1-800-222-1222) immediately.

Purpose

Purpose: Topical anesthetic

Warnings

Warnings: For external use only

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • with or at the same times as other external analgesic
  • if you are allergic to any ingredients of this product

When using this product

  • do not use otherwise than as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within 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 (1-800-222-1222) immediately.

Directions

Adult 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
  • Remove patch from skin after at most 8 hours of application

Children under 12 years of age: consult a doctor.

Active Ingredient

Active Ingredient: 0.025% Capsaicin

Other Information (Other information)

Other Information

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

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, Dmdm Hydantoin.

0.025% Capsaicin Pain Relief Patch, Package Ndc Code: 85323 005 01 (0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-005-01)

0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-005-01


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