4% Menthol Cold Therapy Gel

4% Menthol Cold Therapy Gel
SPL v1
SPL
SPL Set ID 66892993-a755-4584-b2a8-2e8d7ac70593
Route
TOPICAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Menthol 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 4%

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 pain relief

Section 42229-5

Compare to Biofreeze® Menthol Pain Relieving Gel active ingredient

Cooling Pain Relief | Menthol Topical Analgesic

For Minor Aches & Muscle Pain

COOLING MENTHOL FORMULA

• For Arthritis Backache

• Joint & Muscle Pain

• Fast-Acting and Long-Lasting

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

When using this product

avoid contact with eyes • do not apply to wounds or damaged skin 

• do not bandage tightly • do not use with heating pads or heating devices

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable: Keep away from excessive heat or open flame

If pregnant or breastfeeding, ask a health professional before use.

Packaging

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: do not use, consult a doctor

• wash hands after use with cool water

Drug Facts

Active Ingredient

Menthol 4%

Other Information

• store in a cool dry place away from direct sunlight • store with cap closed tightly

Inactive Ingredients

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


Structured Label Content

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 pain relief

Section 42229-5 (42229-5)

Compare to Biofreeze® Menthol Pain Relieving Gel active ingredient

Cooling Pain Relief | Menthol Topical Analgesic

For Minor Aches & Muscle Pain

COOLING MENTHOL FORMULA

• For Arthritis Backache

• Joint & Muscle Pain

• Fast-Acting and Long-Lasting

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

Topical analgesic

Warnings

For external use only

When using this product

avoid contact with eyes • do not apply to wounds or damaged skin 

• do not bandage tightly • do not use with heating pads or heating devices

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable: Keep away from excessive heat or open flame

If pregnant or breastfeeding, ask a health professional before use.

Packaging

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: do not use, consult a doctor

• wash hands after use with cool water

Drug Facts

Active Ingredient

Menthol 4%

Other Information (Other information)

• store in a cool dry place away from direct sunlight • store with cap closed tightly

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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