SANITIZING ISOPROPYL ALCOHOL WIPES- hand sanitizer cloth 
Unitrex 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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Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Isopropyl alcohol Antiseptic Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

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.

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

purified water USP

Package Label - Principal Display Panel

80 Wipes NDC: 78553-3920-1 Package Label

SANITIZING ISOPROPYL ALCOHOL WIPES 
hand sanitizer cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78553-3920
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 25 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78553-3920-1370 g in 1 CAN; Type 0: Not a Combination Product08/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/27/2020
Labeler - Unitrex Ltd. (062032343)
Registrant - Unitrex Ltd. (062032343)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Wellbeing Technology Co., Ltd.414010999manufacture(78553-3920)

Revised: 8/2020
Document Id: add2d45e-4d4d-8c88-e053-2995a90a75ce
Set id: add2d92d-7159-94d7-e053-2a95a90ad948
Version: 1
Effective Time: 20200827
 
Unitrex Ltd.