THERA CARE COLD HOT MEDICATED PATCH- menthol patch 
Veridian Healthcare

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Thera Care Cold Hot Medicated Patch

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

Packlabel

THERA CARE COLD HOT MEDICATED PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-954
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-954-055 in 1 BOX10/01/2020
19 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2020
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
Unexo Life Sciences, Private Limited872260479manufacture(71101-954)

Revised: 1/2023
Document Id: f1fe7ee0-7b72-3f74-e053-2a95a90a5893
Set id: b1ce129d-06a1-7755-e053-2995a90abd7d
Version: 2
Effective Time: 20230111
 
Veridian Healthcare