WINCO COLD AND HOT MEDICATED PATCH LARGE- menthol patch 
WINCO FOODS, 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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Winco Cold & Hot Medicated Patch Large, 5ct, ZDP, (24192A)

Active ingredient..................................Purpose

Methol 5%................................Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

Warnings

For external use only

Ask a doctor before use if you have

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

-open pouch and remove patch

-carefully peel off protective backing and apply sticky side to affected area

-adults and children 12 years of age and older:

-children under 12 years of age: consult a doctor

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:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN CHINA

24192A

WINCO COLD AND HOT MEDICATED PATCH LARGE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-914
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TARTARIC ACID (UNII: W4888I119H)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-914-055 in 1 CARTON09/11/2020
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 finalpart34809/11/2020
Labeler - WINCO FOODS, LLC (056098817)

Revised: 3/2022
Document Id: db8bdbdb-cd3a-0e05-e053-2a95a90ad7be
Set id: af0d86c4-f74e-2dbe-e053-2a95a90a74c1
Version: 6
Effective Time: 20220331
 
WINCO FOODS, LLC