Hot And Cold Medicated Patch

Hot And Cold Medicated Patch
SPL v6
SPL
SPL Set ID 1630e996-5243-4fb4-9c91-216fb8e65800
Route
TOPICAL
Published
Effective Date 2017-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-01

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

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis

■ muscle strains ■ muscle sprains ■ bruises ■ 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 4 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

When Using This Product

Use only as directed ■ Don’t bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

Stop Use and Ask A Doctor

If condition worsens ■ If redness is present ■ If irritation develops

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

If Pregnant Or Breastfeeding

ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control


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)

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis

■ muscle strains ■ muscle sprains ■ bruises ■ 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 4 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 ■ Don’t bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If condition worsens ■ If redness is present ■ If irritation develops

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

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)

If swallowed, get medical help or contact a Poison Control


Advanced Ingredient Data


Raw Label Data

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