ANTISEPTIC HAND SANITIZER VERSACE- alcohol gel

Antiseptic Hand sanitizer VERSACE by

Drug Labeling and Warnings

Antiseptic Hand sanitizer VERSACE by is a Otc medication manufactured, distributed, or labeled by V-SHAPES SRL, Orlandi Inc., Accurate Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use 

in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

Carbomer, imidazolidinyl urea, PEG-12 dimethicone, propylene chlorhexidine gluconate, triethanolamine, water.

Questions?

1-(888) 408-1694

Package Labeling:

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER VERSACE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74785-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
IMIDUREA (UNII: M629807ATL)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74785-003-00	5 in 1 BOX	07/01/2020
1		3 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/01/2020

Labeler - V-SHAPES SRL (438846579)

Establishment
Name	Address	ID/FEI	Business Operations
Orlandi Inc.		079801467	pack(74785-003) , label(74785-003)

Establishment
Name	Address	ID/FEI	Business Operations
Accurate Labs, LLC		113427259	manufacture(74785-003)