Healthwise Cold Therapy Pain Relief Patch

Healthwise Cold Therapy Pain Relief Patch
SPL v3
SPL
SPL Set ID 0ce356e0-90a3-ad52-e063-6294a90a404a
Route
TOPICAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Phenoxyethanol Arnica Montana Flower Propylene Glycol Tartaric Acid Povidone Carboxymethylcellulose Sodium, Unspecified Form Sodium Polyacrylate (8000 Mw) Mineral Oil Water Polyacrylic Acid (8000 Mw) Diazolidinyl Urea Aloe Vera Leaf Ethylhexylglycerin Glycerin Titanium Dioxide Kaolin Petrolatum Polysorbate 80 Iodopropynyl Butylcarbamate Green Tea Leaf Frankincense

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Use

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

Warnings

For external use only

Directions

Directions

■ Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove back ng starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

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

Active Ingredient

Menthol 5%

Other Information

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

Inactive Ingredient

aloe vera extract, arnica montana extract, boswellia carterii resin extract, carboxymethylcellulose sodium, ethylhexylglycerin, dihydroxyaluminum aminoacetate, glycerin, green tea extract, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

When Using This Product

■Use only as directed ■ Rare cases of serious burns have been reported with products of this type ■Don't bandage tightly or use with heating pad ■ Avoid contact with eyes and mucous membranes ■Don't apply to wounds or damaged skin ■ Do not use at the same time as other topical analgesics.

If Pregnant Or Breast Feeding

ask a health professional before use.

Stop Use and Consult A Doctor If

o condition worsens

o redness is present

o irritation develops

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

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

Healthwise Cold Therapy Pain Relief Patch


Structured Label Content

Use

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

Purpose

Topical analgesic

Warnings

For external use only

Directions

Directions

■ Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove back ng starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

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

Active Ingredient

Menthol 5%

Other Information (Other information)

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

Inactive Ingredient

aloe vera extract, arnica montana extract, boswellia carterii resin extract, carboxymethylcellulose sodium, ethylhexylglycerin, dihydroxyaluminum aminoacetate, glycerin, green tea extract, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

When Using This Product (When using this product)

■Use only as directed ■ Rare cases of serious burns have been reported with products of this type ■Don't bandage tightly or use with heating pad ■ Avoid contact with eyes and mucous membranes ■Don't apply to wounds or damaged skin ■ Do not use at the same time as other topical analgesics.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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

o condition worsens

o redness is present

o irritation develops

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

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

Healthwise Cold Therapy Pain Relief Patch (HealthWise Cold Therapy Pain Relief Patch)


Advanced Ingredient Data


Raw Label Data

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