SPL v1
SPL
SPL Set ID 36edbc3f-501c-c1ea-e063-6394a90af6af
Route
TOPICAL
Published
Effective Date 2025-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Carbomer Cannabis Sativa Seed Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Dimethyl Sulfone Pyridoxine Hcl Allantoin Aloe Barbadensis Leaf Juice Arnica Montana Flower Butyrospermum Parkii (shea) Butter C13-14 Isoparaffin Cinnamomum Camphora (camphor) Bark Oil Dimethyl Isosorbide Ethoxydiglycol Glycerin Glyceryl Stearate Isopropyl Myristate .alpha.-tocopherol Acetate, D- Triethanolamine Water Boswellia Serrata Resin Oil Centella Asiatica Leaf Dipotassium Glycyrrhizate Emu Oil Helianthus Annuus (sunflower) Seed Oil Laureth-7 Lavandula Angustifolia (lavender) Oil Phenoxyethanol Polysorbate 20 Sodium Benzoate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Dimethicone Disodium Edta-copper Eucalyptus Globulus Leaf Oil Peg-100 Stearate Polyacrylamide (10000 Mw)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-06

Description

Active Ingredient Menthol 4%


Medication Information

Warnings and Precautions

Warnings

■ For external use only.

■ Avoid contact with the eyes.

■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

■ Do not apply to wounds or damaged skin.

■ Do not bandage tightly.

Indications and Usage

Uses

■ For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. ■ Provides cooling and warming pain relief.

Dosage and Administration

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Description

Active Ingredient Menthol 4%

Section 50565-1

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

Section 51727-6

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Resin Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa Seed Oil, Carbomer, Centella Asiatica Leaf Extract, Cinnamomum Camphora (Camphor) Bark Oil, Dimethicone, Dimethyl Isosorbide, Dipotassium Glycyrrhizate, Disodium EDTA, Emu Oil, Ethoxydiglycol, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methyl Sulfonyl Methane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 20, Pyridoxine HCl, Sodium Benzoate, Tocopheryl Acetate, Triethanolamine, Water

Section 51945-4

Section 55105-1

Active Ingredient Purpose

Menthol 4% Topical Analgesic

Section 55106-9

Active Ingredient

Menthol 4%


Structured Label Content

Indications and Usage (34067-9)

Uses

■ For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. ■ Provides cooling and warming pain relief.

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

■ For external use only.

■ Avoid contact with the eyes.

■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

■ Do not apply to wounds or damaged skin.

■ Do not bandage tightly.

Section 50565-1 (50565-1)

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

Section 51727-6 (51727-6)

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Resin Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa Seed Oil, Carbomer, Centella Asiatica Leaf Extract, Cinnamomum Camphora (Camphor) Bark Oil, Dimethicone, Dimethyl Isosorbide, Dipotassium Glycyrrhizate, Disodium EDTA, Emu Oil, Ethoxydiglycol, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methyl Sulfonyl Methane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 20, Pyridoxine HCl, Sodium Benzoate, Tocopheryl Acetate, Triethanolamine, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Active Ingredient Purpose

Menthol 4% Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredient

Menthol 4%


Advanced Ingredient Data


Raw Label Data

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