42c93789-9758-54b7-e063-6394a90ac398

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

Active Ingredient

Active Ingredient

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

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 60561-8

Other Information

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active Ingredient

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

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

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 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)