V-KLEAN by Asiaticon, S.A. de C.V. / ASIATICON, S.A de C.V. V-KLEAN- alcohol gel

V-KLEAN by

Drug Labeling and Warnings

V-KLEAN by is a Otc medication manufactured, distributed, or labeled by Asiaticon, S.A. de C.V., ASIATICON, S.A de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Warnings

Flammable, keep away from fire and flames

For external use only

Inactive ingredients

Aminomethylpropanol, glycerin, polyacrylic acidc (Carbomer), purified water USP.

Use

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

KEEP OUT OF REACH OF CHILDREN

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

Purpose

Antiseptic, Hand sanitizer

Active Ingredient(s)

Alcohol 70% Purpose: Antiseptic

PRINCIPAL DISPLAY PANEL

250 mL NDC: 75192-002-01

Package Label - Principal Display Panel

500 mL NDC: 75192-002-02

Package Label - Principal Display Panel

1.5 mL NDC: 75192-002-04

INGREDIENTS AND APPEARANCE

V-KLEAN 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75192-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.5 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.35 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.85 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75192-002-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2020
2	NDC: 75192-002-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2020
3	NDC: 75192-002-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2020	08/20/2020
4	NDC: 75192-002-04	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	06/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/16/2020

Labeler - Asiaticon, S.A. de C.V. (951576254)

Registrant - Asiaticon, S.A. de C.V. (951576254)

Establishment
Name	Address	ID/FEI	Business Operations
ASIATICON, S.A de C.V.		951576254	manufacture(75192-002)