LK NEW ANTISEPTIC ETHANOL- alcohol liquid

LK New Antiseptic Ethanol by

Drug Labeling and Warnings

LK New Antiseptic Ethanol by is a Otc medication manufactured, distributed, or labeled by Venice Cosmetic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethanol 83%

Uses

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

Purpose

Antibacterial

Warnings

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

Do not use

if you are allergic to any of the ingredients
in children less than 2 months of age
on open skin wounds

When using this product avoid contact with 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.

If pregnant or breast-feeding, ask a health professional before use.

Directions

• Take appropriate amount onto your hand and spread it all the way to fingertips. Rub hands together until dry.
• Supervise Children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Water

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

LK New Antiseptic Ethanol

INGREDIENTS AND APPEARANCE

LK NEW ANTISEPTIC ETHANOL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74488-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	83 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74488-010-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/09/2020

LK NEW ANTISEPTIC ETHANOL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74488-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	83 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74488-011-01	255 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/09/2020

Labeler - Venice Cosmetic (695047082)

Establishment
Name	Address	ID/FEI	Business Operations
Venice Cosmetic		695047082	manufacture(74488-010, 74488-011)