HAND SANITIZING WIPES- alcohol cloth 
SUMEC Hardware & Tools Co., Ltd.

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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SUMEC, Wipes, 80% Ethyl alcohol, 50*4

Active Ingredient

Ethyl alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Sanitizing wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Flammable. Keep away from heat or flame. For external use only. Not for use as a baby wipe.

Do not use

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Glycerol, Aloe extract, Sodium Hyaluronate, Trolamine, Water (aqua), Denatonium

Package Label - Principal Display Panel

Principal Display PanelPouchCarton

HAND SANITIZING WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74035-2051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL4.5 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74035-2051-24 in 1 CARTON09/03/2020
1NDC:74035-2051-150 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/03/2020
Labeler - SUMEC Hardware & Tools Co., Ltd. (654687771)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
SUMEC Hardware & Tools Co., Ltd.654687771manufacture(74035-2051) , label(74035-2051)

Revised: 9/2020
Document Id: ae6d905c-ca6f-15a2-e053-2995a90a0641
Set id: ae6d905c-ca6e-15a2-e053-2995a90a0641
Version: 1
Effective Time: 20200903
 
SUMEC Hardware & Tools Co., Ltd.