Extra Strength Cold & Hot Menthol Patch

Extra Strength Cold & Hot Menthol Patch
SPL v4
SPL
SPL Set ID bd46ac50-aaf8-b4e8-e053-2995a90aea61
Route
TOPICAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (5 g)
Inactive Ingredients
Carboxymethylcellulose Sodium Petrolatum Dihydroxyaluminum Aminoacetate Glycerin Kaolin Polyacrylic Acid (8000 Mw) Phenoxyethanol Polysorbate 80 Polyethylene Glycol 400 Povidone, Unspecified Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Water Iodopropynyl Butylcarbamate Ethylhexylglycerin Mineral Oil

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Dosage and Administration

Directions Adults and children 12 years of age and over : ■ Carefully remove backing from patch ■ Apply sticky side of patch to affected area. ■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily.. ■ Discard patch after single use. ■Reseal pouch after opening. ■Children under 12 years of age: consult a physician.


Medication Information

Dosage and Administration

Directions Adults and children 12 years of age and over :

■ Carefully remove backing from patch

■ Apply sticky side of patch to affected area.

■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily..

■ Discard patch after single use.

■Reseal pouch after opening.

■Children under 12 years of age: consult a physician.

Description

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Uses

Temporarily relieves minor pain.

Section 53414-9

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

Warnings

For external use only.

Active Ingredients

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Inactive Ingredients

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, mineral oil, petrolatum, Phenoxyethanol, polyacrylic acid, Polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product

■ use only as directed

■ rear cases of serious burns have been reported with products of this type

■ Don't bandage tightly or use with a heating pad

■ Avoid contact with the eyes and mucous membranes

■Don't apply to wounds or damaged skin

■ Do not use at the same time as other topical analgesics

Other Safety Information

Store at room temperature, not to exceed 86F (30C)

Stop Use and Consult A Doctor

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Extra Strength Cold & Hot Menthol Patch

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.


Structured Label Content

Uses

Temporarily relieves minor pain.

Section 53414-9 (53414-9)

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

Warnings

For external use only.

Active Ingredients

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Inactive Ingredients

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, mineral oil, petrolatum, Phenoxyethanol, polyacrylic acid, Polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product (When using this product)

■ use only as directed

■ rear cases of serious burns have been reported with products of this type

■ Don't bandage tightly or use with a heating pad

■ Avoid contact with the eyes and mucous membranes

■Don't apply to wounds or damaged skin

■ Do not use at the same time as other topical analgesics

Other Safety Information

Store at room temperature, not to exceed 86F (30C)

Dosage and Administration

Directions Adults and children 12 years of age and over :

■ Carefully remove backing from patch

■ Apply sticky side of patch to affected area.

■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily..

■ Discard patch after single use.

■Reseal pouch after opening.

■Children under 12 years of age: consult a physician.

Stop Use and Consult A Doctor (Stop use and consult a doctor)

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Extra Strength Cold & Hot Menthol Patch

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.


Advanced Ingredient Data


Raw Label Data

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