SPL v1
SPL
SPL Set ID 42c93789-9758-54b7-e063-6394a90ac398
Route
TOPICAL
Published
Effective Date 2025-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.04 g)
Inactive Ingredients
Fd&c Yellow No. 5 Trolamine Silicon Dioxide Ilex Paraguariensis Leaf Water Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol, D- Frankincense Fd&c Blue No. 1 Green Tea Leaf Arnica Montana Flower Glycerin Camphor (synthetic) Alcohol 95% Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-03

Description

Active Ingredient Menthol 4.0% w/w ...... Purpose: Topical Analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

When using this product

• Avoid contact with eyes or mucous membranes

• Do not apply to wounds or damaged skin

• Do not use with other ointments, creams, sprays, or liniments

• Do not apply to irritated skin or if excessive irritation develops

• Do not bandage

• Wash hands after use with cool water

• Do not use with a heating pad or device

• Store in a cool, dry place

Stop use if

• Condition worsens or if symptoms persist for more than 7 days, or clear up and recur.

Dosage and Administration

Directions

Adults and children 12 years of age and over:

  • Rub a thin film over affected areas not more than 4 times daily
  • Massage not necessary

Children under 12 years old: Consult physician

Description

Active Ingredient Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Section 43685-7

Flammable

• Keep away from fire or flame

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact the Poison Control Center immediately.

Section 50569-3

Ask a doctor if

Condition worsens or if symptoms persist for more than 7 days. or clear up and reoccur.

Section 51727-6

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Section 51945-4

Section 53413-1

Questions or Comments

Call +1-888-806-6834

Section 53414-9

If pregnant or breast-feeding

  • Ask a health professional before use
Section 55105-1

Purpose

(Menthol) Topical Analgesic

Section 55106-9

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Section 60561-8

Other Information

  • Avoid storing the product in direct sunlight
  • Protect the product from excessive moisture.

Structured Label Content

Indications and Usage (34067-9)

Use

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

When using this product

• Avoid contact with eyes or mucous membranes

• Do not apply to wounds or damaged skin

• Do not use with other ointments, creams, sprays, or liniments

• Do not apply to irritated skin or if excessive irritation develops

• Do not bandage

• Wash hands after use with cool water

• Do not use with a heating pad or device

• Store in a cool, dry place

Stop use if

• Condition worsens or if symptoms persist for more than 7 days, or clear up and recur.

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and over:

  • Rub a thin film over affected areas not more than 4 times daily
  • Massage not necessary

Children under 12 years old: Consult physician

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 43685-7 (43685-7)

Flammable

• Keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact the Poison Control Center immediately.

Section 50569-3 (50569-3)

Ask a doctor if

Condition worsens or if symptoms persist for more than 7 days. or clear up and reoccur.

Section 51727-6 (51727-6)

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments

Call +1-888-806-6834

Section 53414-9 (53414-9)

If pregnant or breast-feeding

  • Ask a health professional before use
Section 55105-1 (55105-1)

Purpose

(Menthol) Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Section 60561-8 (60561-8)

Other Information

  • Avoid storing the product in direct sunlight
  • Protect the product from excessive moisture.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)