85323-006, 5% Menthol Pain Relief Patch

85323-006, 5% Menthol Pain Relief Patch
SPL v3
SPL
SPL Set ID 37895254-c092-1200-e063-6394a90a51b7
Route
TOPICAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Water Polysorbate 80 Kaolin Sodium Polyacrylate (2500000 Mw) Carbomer 934 Glycerin Dmdm Hydantoin Carboxymethylcellulose Sodium Edetate Disodium Dihydroxyaluminum Aminoacetate Anhydrous Povidone K90 Tartaric Acid Alcohol 95%

Identifiers & Packaging

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

Description

5% Menthol Pain Relief Patch, Package NDC Code 85323-006-01

Purpose

Purpose: Topical anesthetic


Medication Information

Indications and Usage

Temporarily relieves minor pains associated with:

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

Adult and Children 12 years of age and older:

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used to 8 hours
  • ashould be used no more than 3 times a day
  • Children under 12 years of age: consult a doctor
Purpose

Purpose: Topical anesthetic

Description

5% Menthol Pain Relief Patch, Package NDC Code 85323-006-01

Uses

Uses

Temporarily relieves minor pains associated with:

  • arthritis
  • simple backache
  • muscle strains
  • bursitis
  • tendonitis
  • sprains
  • bruises
  • cramps
Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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
  • do not bandage tightly or use with a heating pad
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin.

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few day
  • 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 right away.

Directions

Directions

Adult and children 12 years of age and older:

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used to 8 hours
  • ashould be used no more than 3 times a day
  • Children under 12 years of age: consult a doctor
Active Ingredient

Active Ingredient: Menthol 5%

Other Information

Other Information

  • store at roo temperature 68 to 77℉ (20 to 25℃)
Inactive Ingredients
5% Menthol Pain Relief Patch, Package Ndc Code 85323 006 01

Structured Label Content

Uses

Uses

Temporarily relieves minor pains associated with:

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

Temporarily relieves minor pains associated with:

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

Adult and Children 12 years of age and older:

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used to 8 hours
  • ashould be used no more than 3 times a day
  • 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

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
  • do not bandage tightly or use with a heating pad
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged skin.

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few day
  • 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 right away.

Directions

Directions

Adult and children 12 years of age and older:

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used to 8 hours
  • ashould be used no more than 3 times a day
  • Children under 12 years of age: consult a doctor
Active Ingredient

Active Ingredient: Menthol 5%

Other Information (Other information)

Other Information

  • store at roo temperature 68 to 77℉ (20 to 25℃)
Inactive Ingredients
5% Menthol Pain Relief Patch, Package Ndc Code 85323 006 01 (5% Menthol Pain Relief Patch, Package NDC Code 85323-006-01)

Advanced Ingredient Data


Raw Label Data

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