4% Menthol Pain Relief Gel

4% Menthol Pain Relief Gel
SPL v1
SPL
SPL Set ID 7fb95135-4151-4ef4-bb6d-75251cafff6c
Route
TOPICAL
Published
Effective Date 2026-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Aloe Vera Leaf Juice Arctium Lappa Whole Arnica Montana Flower Aminomethylpropanol Indian Frankincense Butylene Glycol Calendula Officinalis Flower Green Tea Leaf Camphor (natural) Carbomer Homopolymer, Unspecified Type Fd&c Blue No. 1 Fd&c Yellow No. 5 Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf Methyl Methacrylate/glycol Dimethacrylate Crosspolymer .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-19

Description

Menthol 4%

Purpose

Pain Relief Gel


Medication Information

Purpose

Pain Relief Gel

Description

Menthol 4%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Section 42229-5

COOLING MENTHOL FORMULA

✓ Soothes sore muscles

✓ Relieves back, neck & joint pain

✓ Fast-absorbing & non-greasy

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road, Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

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.

Flammable: Keep away from excessive heat or open flame

When using this product • use only as directed • avoid contact with the eyes or on mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if ​• you experience pain, swelling or blistering of the skin • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• adults and children 12 years of age and older: rub a thin film over affected area not more than3 to 4 times daily • children under 12 years of age: consult a physician • wash hands after use with cool water

Drug Facts

Active Ingredient

Menthol 4%

Other Information

Store at room temperature • Protect from direct sunlight.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Arctium Lappa Extract, Arnica Montana Flower Extract, Aminomethyl Propanol, Boswellia Serrata Extract, Butylene Glycol, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water.


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Section 42229-5 (42229-5)

COOLING MENTHOL FORMULA

✓ Soothes sore muscles

✓ Relieves back, neck & joint pain

✓ Fast-absorbing & non-greasy

Mfd for and Distributed by:

Universal Distribution Center LLC

330 Applegarth Road, Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

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

Pain Relief Gel

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product • use only as directed • avoid contact with the eyes or on mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if ​• you experience pain, swelling or blistering of the skin • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• adults and children 12 years of age and older: rub a thin film over affected area not more than3 to 4 times daily • children under 12 years of age: consult a physician • wash hands after use with cool water

Drug Facts (Drug facts)

Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)

Store at room temperature • Protect from direct sunlight.

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Arctium Lappa Extract, Arnica Montana Flower Extract, Aminomethyl Propanol, Boswellia Serrata Extract, Butylene Glycol, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water.


Advanced Ingredient Data


Raw Label Data

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