TOPCARE COLD AND HOT MEDICATED- menthol patch 
Topco Associates LLC

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.

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Topcare Cold & Holt Medicated Patch 5 ct. Large

Active ingredient Purpose

Menthol 5%..................................................Topical analgesic

Uses

Warnings

For external use only

Do not use

Ask a doctor before use if you have

redness over the affected area

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

Other information

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Distributed by:

Topco Associates LLC

Elk Grove Village, IL 60007

Made in China

15098A

TOPCARE COLD AND HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-860
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALCOHOL (UNII: 3K9958V90M)  
KAOLIN (UNII: 24H4NWX5CO)  
TARTARIC ACID (UNII: W4888I119H)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-860-055 in 1 BOX04/23/2019
11 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/23/2019
Labeler - Topco Associates LLC (006935977)

Revised: 12/2022
Document Id: efe77dbd-f918-6230-e053-2a95a90a7222
Set id: 8739aedd-165c-5ae0-e053-2a91aa0afcd0
Version: 4
Effective Time: 20221215
 
Topco Associates LLC