1451 - Ndc 67777-145-10

1451 - Ndc 67777-145-10
SPL v1
SPL
SPL Set ID 7a1449c9-7a44-412d-e053-2991aa0a6649
Route
TOPICAL
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg)
Inactive Ingredients
Edetic Acid Isopropyl Myristate Polyvinyl Alcohol, Unspecified Polysorbate 80 Tartaric Acid Glycerin Sodium Polyacrylate (2500000 Mw) Aluminum Hydroxide Titanium Dioxide Water Castor Oil Kaolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-08-15
Description

Menthol 5%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Use

Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, strains, sprains, bruises

Section 50565-1

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

Warnings

For external use only

Directions

Adults 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
  • wear each patch up to 8 hours maximum

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

Active Ingredient

Menthol 5%

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

Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Label Ndc 67777 145 10

Label Ndc 67777 145 20

Label Ndc 67777 145 30

When Using This Product

use only as directed, avoid contact with the eyes, mucous membranes or rashes

Stop Use and Ask A Doctor If
  • excessive redness or irritation is present
  • conditions 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.

Structured Label Content

Use

Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, strains, sprains, bruises

Section 50565-1 (50565-1)

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

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults 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
  • wear each patch up to 8 hours maximum

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

Active Ingredient (Active ingredient)

Menthol 5%

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

Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Label Ndc 67777 145 10 (Label NDC 67777-145-10)

Label Ndc 67777 145 20 (Label NDC 67777-145-20)

Label Ndc 67777 145 30 (Label NDC 67777-145-30)

When Using This Product (When using this product)

use only as directed, avoid contact with the eyes, mucous membranes or rashes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • excessive redness or irritation is present
  • conditions 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:40.225429 · Updated: 2026-03-14T22:55:18.422436