IMEI 2nd submittal 203-01

Alcohol Wipe by

Drug Labeling and Warnings

Alcohol Wipe by is a Otc medication manufactured, distributed, or labeled by IMEI CHEMICAL ENTERPRISE LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL WIPE- alcohol cloth 
IMEI CHEMICAL ENTERPRISE 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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IMEI 2nd submittal 203-01

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only, do not inhale or ingest

Flammable keep away from fireor flame or direct sunlight

When using the product keep out of eyes. In case of eye contact, flush thoroughly with water and get medical help

For children under 6, use only under adult supervision. Keep out of reach of children.

Directions

  • Open packet, remove and unfold wipe, wipe hands thoroughly, do not flush.

Other information

Do not store above 105F/40C. Store in a cool dry place, away for direct sunlight.

Inactive ingredients

Water

Package Label - Principal Display Panel

Front and Back LabelsOne Wipe, NDC: 77660-203-01

ALCOHOL WIPE 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77660-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77660-203-011 mL in 1 PACKET; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/202007/13/2021
Labeler - IMEI CHEMICAL ENTERPRISE LTD. (657454100)
Establishment
NameAddressID/FEIBusiness Operations
IMEI CHEMICAL ENTERPRISE LTD.657454100manufacture(77660-203)

Revised: 7/2021
Document Id: c70633b1-5245-03ca-e053-2995a90af861
Set id: a96cdc0f-e56d-493e-e053-2a95a90a63e8
Version: 2
Effective Time: 20210713