Extra Large Cool And Heat Patch

Extra Large Cool And Heat Patch
SPL v4
SPL
SPL Set ID 9fd83f89-0dd0-4f22-9c8e-a353864ea43b
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Petrolatum Mineral Oil Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Sodium Polyacrylate (2500000 Mw) Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Propylparaben Povidone, Unspecified Carboxymethylcellulose Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

Description

Active Ingredient ...............................................................................................Purpose Menthol 5%...............................................................................................Topical Analgesic

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Active Ingredient ...............................................................................................Purpose Menthol 5%...............................................................................................Topical Analgesic

Section 51945-4

Warnings

For External Use Only.

Active Ingredient

Active Ingredient ...............................................................................................Purpose

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

Inactive Ingredient

CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Indications & Usage

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

Dosage & Administration

Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

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.

Stop Use and Ask 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.

If Pregnant Or Breastfeeding

ask a health professional before use.

Keep Out of Reach of Children

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.


Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Topical Analgesic

Warnings (WARNINGS)

For External Use Only.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient ...............................................................................................Purpose

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

Inactive Ingredient (INACTIVE INGREDIENT)

CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Indications & Usage (INDICATIONS & USAGE)

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

Dosage & Administration (DOSAGE & ADMINISTRATION)

Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

When Using This Product (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.

Stop Use and Ask A Doctor (Stop use and ask 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.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Do not use on infants. 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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