Cold And Hot Medicated Patch

Cold And Hot Medicated Patch
SPL v7
SPL
SPL Set ID c19aa620-401d-43c4-804c-3611cc39e9f2
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.05 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Edetate Disodium Ethylhexylglycerin Glycerin Phenoxyethanol Povidone, Unspecified Carboxymethylcellulose Sodium, Unspecified Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-25

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Uses

Temporarily relieve minor pain associated with:

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

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

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

Warnings

For external use only.

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.

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.

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

Packaging

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

Drug Facts

Active Ingredient

Menthol 5%

Other Information

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

Inactive Ingredients

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


Structured Label Content

Uses

Temporarily relieve minor pain associated with:

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purpose

Topical analgesic

Warnings (WARNINGS)

For external use only.

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.

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.

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

Packaging

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

Drug Facts

Active Ingredient

Menthol 5%

Other Information

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

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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