85323-008, 3% Menthol Plus 0.083% Capsaicin Pain Relief Patch

85323-008, 3% Menthol Plus 0.083% Capsaicin Pain Relief Patch
SPL v3
SPL
SPL Set ID 378a6887-c609-b79c-e063-6394a90a00f4
Route
TOPICAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g) Capsaicin (83 mg)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Alcohol 95% Water Dihydroxyaluminum Aminoacetate Anhydrous Kaolin Propylene Glycol Edetate Disodium Carbomer 934 Tartaric Acid Polysorbate 80 Povidone K90 Glycerin Carboxymethylcellulose Sodium Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-10

Description

3% Menthol plus 0.083% Capsaicin Pain Relief Patch, Package NDC Code: 85323-008-01

Purpose

Purpose: Topical anesthetic


Medication Information

Indications and Usage

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • bruises
  • cramps

Adult and children 12 years of age and older:

  • Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
  • Apply to affected area not more than 3 to 4 times daily



Children under 12 years of age: DO NOT use without consulting a doctor.

Purpose

Purpose: Topical anesthetic

Description

3% Menthol plus 0.083% Capsaicin Pain Relief Patch, Package NDC Code: 85323-008-01

Uses

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • bruises
  • cramps
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: EXTERNAL USE ONLY

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • aviod contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

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

DIRECTIONS

Adult and children 12 years of age and older:

  • Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
  • Apply to affected area not more than 3 to 4 times daily



Children under 12 years of age: DO NOT use without consulting a doctor.

Active Ingredient

Active Ingredients (in each gram):

Menthol 30mg

Capsaicin 0.83mg

Other Information

Other Information

  • store at room temperature 68 to 77℉ (20-25℃)
Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, Povidone K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80, Propylene Glycol.

3% Menthol Plus 0.083% Capsaicin Pain Relief Patch, Package Ndc Code: 85323 008 01

3% Menthol plus 0.083% Capsaicin Pain Relief Patch, Package NDC Code: 85323-008-01


Structured Label Content

Uses

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • bruises
  • cramps
Indications and Usage (34067-9)

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • bruises
  • cramps

Adult and children 12 years of age and older:

  • Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
  • Apply to affected area not more than 3 to 4 times daily



Children under 12 years of age: DO NOT use without consulting 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: EXTERNAL USE ONLY

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • aviod contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

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

DIRECTIONS

Adult and children 12 years of age and older:

  • Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
  • Apply to affected area not more than 3 to 4 times daily



Children under 12 years of age: DO NOT use without consulting a doctor.

Active Ingredient

Active Ingredients (in each gram):

Menthol 30mg

Capsaicin 0.83mg

Other Information (Other information)

Other Information

  • store at room temperature 68 to 77℉ (20-25℃)
Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, Povidone K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80, Propylene Glycol.

3% Menthol Plus 0.083% Capsaicin Pain Relief Patch, Package Ndc Code: 85323 008 01 (3% Menthol plus 0.083% Capsaicin Pain Relief Patch, Package NDC Code: 85323-008-01)

3% Menthol plus 0.083% Capsaicin Pain Relief Patch, Package NDC Code: 85323-008-01


Advanced Ingredient Data


Raw Label Data

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