LACTONE HAND SANITIZER WIPE- alcohol cloth 
ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI

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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Hand Sanitizer Wipes

Active Ingredient(s)

Ethyl Alcohol 80%

Purpose

Antiseptic

Use

Use for hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

Flammable, keep away from heat and flames. For external use only

When using this product

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or rash occurs.

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

Directions

wet hands thorougly with product and allow to dry without wiping

Inactive ingredients

water, Aloe Barbadensis Leaf Extract and propylene glycol

Package Label - Principal Display Panel

Producer

ALL ONE KOZMETIK SAN. VE DIS. TIC. A. S.

Sutluce Mahallesi

Uzunbayır Sokak No:44/4

Beyoglu/Istanbul

Net weight: 5 gr

MADE IN TURKEY

Hand Sanitizer Wipe

Kills 99.99% of E. coli, Salmonella enterica and Staphylococcus aureus (MRSA)

with ALOE VERA FRAGRANCE

For External Use only

LACTONE HAND SANITIZING WIPES- alcohol cloth

puch

Package

LACTONE HAND SANITIZER WIPE 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75348-888
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75348-888-055 g in 1 POUCH; Type 0: Not a Combination Product05/22/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/22/2020
Labeler - ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI (519983719)
Registrant - HARDAL GLOBAL CONSULTING LLC. (123584960)
Establishment
NameAddressID/FEIBusiness Operations
ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI519983719manufacture(75348-888)

Revised: 6/2020
Document Id: a85e8bd8-bee6-8957-e053-2995a90a914f
Set id: a85e92a2-5702-5957-e053-2a95a90a6a9e
Version: 1
Effective Time: 20200618
 
ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI