ALCOSHIELD- ethyl alcohol gel

AlcoShield by

Drug Labeling and Warnings

AlcoShield by is a Otc medication manufactured, distributed, or labeled by Atlas R & D Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 75% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

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

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

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.

STOP USE

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

DOSAGE & ADMINISTRATION

• 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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

purified water USP, carbomer 940, isopropyl alcohol, triethanolamine benzoate, fragrance

PRINCIPAL DISPLAY PANEL

500 mL NDC: 78834-400-03

INGREDIENTS AND APPEARANCE

ALCOSHIELD 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78834-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78834-400-01	1500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/29/2021
2	NDC: 78834-400-02	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/29/2021
3	NDC: 78834-400-03	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/29/2021
4	NDC: 78834-400-04	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/29/2021
5	NDC: 78834-400-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2021
6	NDC: 78834-400-06	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2021
7	NDC: 78834-400-17	1 in 1 CARTON	03/29/2021
7	NDC: 78834-400-07	1.5 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
8	NDC: 78834-400-08	8 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/22/2021

Labeler - Atlas R & D Inc. (257836242)

Establishment
Name	Address	ID/FEI	Business Operations
Atlas R & D Inc.		257836242	manufacture(78834-400) , pack(78834-400)