Thera Care Cold Hot Medicated Patch

Thera Care Cold Hot Medicated Patch
SPL v3
SPL
SPL Set ID b1ce129d-06a1-7755-e053-2995a90abd7d
Route
TOPICAL
Published
Effective Date 2020-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Sorbitan Monooleate Carboxymethylcellulose Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Sodium Polyacrylate (2500000 Mw) Polysorbate 80 Propylparaben Povidone, Unspecified Tartaric Acid Titanium Dioxide Water Polyvinyl Alcohol (100000 Mw) Alcohol Methacrylic Acid And Ethyl Acrylate Copolymer Edetate Disodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

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

Other Information

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

Inactive Ingredient

Inactive ingredients

alcohol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methacrylic ac d and ethyl acrylate copolymer, methylparaben, polysorbate 80, polyvinyl alcohol, povidone, propylparaben, sodium polyacrylate, sorb tan monooleate, sorb tol, tartaric acid, titanium dioxide, water

Indications & Usage

Temporarily relieves minor aches and pains of muscles and joints: ■ 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 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age: Consult a physician.

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 a 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

If condition worsens ■ redness is present ■ If 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 in 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

Other Information

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

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients

alcohol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methacrylic ac d and ethyl acrylate copolymer, methylparaben, polysorbate 80, polyvinyl alcohol, povidone, propylparaben, sodium polyacrylate, sorb tan monooleate, sorb tol, tartaric acid, titanium dioxide, water

Indications & Usage (INDICATIONS & USAGE)

Temporarily relieves minor aches and pains of muscles and joints: ■ 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 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age: 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 a 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)

If condition worsens ■ redness is present ■ If 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 in infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)