THERA CARE COLD HOT MEDICATED PATCH- menthol patch

Thera Care Cold Hot Medicated Patch by

Drug Labeling and Warnings

Thera Care Cold Hot Medicated Patch by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Unexo Life Sciences, Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporarily relieves minor aches and pains of muscles and joints: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis

■ muscle strains ■ muscle sprains ■ bruises ■ cramps

WARNINGS

For External Use Only.

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

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.

Other Information

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

INACTIVE INGREDIENT

Acrylates Copolymer, Alcohol, Carboxymethylcellulose sodium, Edetate Disodium, Dihydroxyaluminium amino acetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Polyvinyl alcohol, Propylparaben, PVP, Sodium Polyacrylate, Sorbitan oleate, Sorbitol, Tartaric Acid, Titanium Dioxide Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERA CARE COLD HOT MEDICATED PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-954
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)
ALCOHOL (UNII: 3K9958V90M)
ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITOL (UNII: 506T60A25R)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-954-05	5 in 1 BOX	10/01/2020
1		9 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2020

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences, Private Limited		872260479	manufacture(71101-954)