LACTONE HAND SANITIZER- alcohol gel

LACTONE HAND SANITIZER by

Drug Labeling and Warnings

LACTONE HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

Use

Hand Sanitizer 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

- in children less than 2 months of age

- on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- Place enough product on hands to cover all surfaces. Rub hands together until dry.

- Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, Carbomer, Triethanolamine, purified water USP

SPL UNCLASSIFIED SECTION

Kills 99.9% of germs without water

For External Use Only

MADE IN TURKEY

Producer

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

Sutluce Mahallesi Uzunbayir Sokak No. 44/4 Beyoglu / Istanbu

PRD: 01.04.2020

EXP: 01.04.2023

Packaging

INGREDIENTS AND APPEARANCE

LACTONE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75348-606
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75348-606-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020
2	NDC: 75348-606-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020
3	NDC: 75348-606-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2020

Labeler - ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI (519983719)

Establishment
Name	Address	ID/FEI	Business Operations
ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI		519983719	manufacture(75348-606)