83559-014

83559-014
SPL v1
SPL
SPL Set ID 49ac6a7b-25d3-6dc4-e063-6394a90a99b6
Route
TOPICAL
Published
Effective Date 2026-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Ethylhexylglycerin Carboxymethylcellulose Sodium, Unspecified Tartaric Acid Titanium Dioxide Water Phenoxyethanol Edetate Disodium Sodium Polyacrylate (2500000 Mw) Glycerin Povidone, Unspecified Dihydroxyaluminum Aminoacetate Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-31

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Use

Temporarily relieve minor pain associated with:

• arthritis • simple backache • muscle strains • bursitis • tendonitis • strains • bruises • cramps

Stop Use

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops.

Warnings

For external use only.

Questions

www.universaldc.com

Ask Doctor

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

Directions

Adults and Children 12 years of age and older:

• peel off protective backing and apply sticky side to affected area

• carefully remove backing from patch

• should be used up to 8 hours

• should be used no more than 3 to 4 times daily

• children under 12 years of age: consult a doctor

When Using

When using this product • use only as directed • do not bandage tightly or use with a heating pad

• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

Active Ingredient

Menthol 5%

Other Information

• store at room temperature 68° to 77°F (20° to 25°C)

Compare to the active ingredient in Icy Hot® Patch

EXTRA STRENGTH

Contains Menthol 5%

Works on contact for cooling pain relief

Pain relieving ointment on a breathable adhesive pad

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

MADE IN CHINA

www.universaldc.com

Inactive Ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Use

Temporarily relieve minor pain associated with:

• arthritis • simple backache • muscle strains • bursitis • tendonitis • strains • bruises • cramps

Purpose

Topical analgesic

Stop Use

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops.

Warnings

For external use only.

Questions

www.universaldc.com

Ask Doctor

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

Directions

Adults and Children 12 years of age and older:

• peel off protective backing and apply sticky side to affected area

• carefully remove backing from patch

• should be used up to 8 hours

• should be used no more than 3 to 4 times daily

• children under 12 years of age: consult a doctor

When Using

When using this product • use only as directed • do not bandage tightly or use with a heating pad

• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

Active Ingredient

Menthol 5%

Other Information (Other information)

• store at room temperature 68° to 77°F (20° to 25°C)

Compare to the active ingredient in Icy Hot® Patch

EXTRA STRENGTH

Contains Menthol 5%

Works on contact for cooling pain relief

Pain relieving ointment on a breathable adhesive pad

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

MADE IN CHINA

www.universaldc.com

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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