SCIGEN HAND SANITIZER- alcohol spray

Scigen Hand Sanitizer by

Drug Labeling and Warnings

Scigen Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Scigen, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:

Organic Ethanol 65%  v/v

PURPOSE

Purpose:

Antiseptic

INDICATIONS & USAGE

Uses:  Hand sanitizer to help reduce viruses and bacteria that potentially can cause disease Recommended for repeated use 

WARNINGS

Warnings:

• Flammable, keep away from fire or flame.
• For external use only
• Do not use in eyes. If contact occurs, flush thoroughly with water.
• Stop use and ask a doctor if redness and irritation develop and persists for more than 72 hours.

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

DOSAGE & ADMINISTRATION

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry Do not use other than directed.

STORAGE AND HANDLING

Other Information:  Store below 86° F

INACTIVE INGREDIENT

Inactive Ingredients: Purified Water, Glycerin, Hydrogen Peroxide

SPL UNCLASSIFIED SECTION

Unscented

Scigen, Inc.

Paramount, CA.

info@scigenus.com

Made in U.S.A.

Packaging

INGREDIENTS AND APPEARANCE

SCIGEN HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74510-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74510-001-02	12 in 1 BOX	05/09/2020
1	NDC: 74510-001-01	110 mL in 1 BOTTLE; 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	part333A	05/09/2020

Labeler - Scigen, Inc (806606166)

Establishment
Name	Address	ID/FEI	Business Operations
Scigen, Inc		806606166	manufacture(74510-001)