AlcoShield by Atlas R & D Inc. AlcoShield

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]

ALCOSHIELD- ethyl alcohol gel 
Atlas R & D Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

AlcoShield

Alcohol 75% v/v. Purpose: Antiseptic

Antiseptic, Hand Sanitizer

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

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

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

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

• 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.

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

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

500 mL NDC: 78834-400-03

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	12/01/2021
2	NDC: 78834-400-02	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/29/2021	12/01/2021
3	NDC: 78834-400-03	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/29/2021	12/01/2021
4	NDC: 78834-400-04	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/29/2021	12/01/2021
5	NDC: 78834-400-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2021	12/01/2021
6	NDC: 78834-400-06	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/29/2021	12/01/2021
7	NDC: 78834-400-17	1 in 1 CARTON	03/29/2021	12/01/2021
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	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/22/2021	12/01/2021

Labeler - Atlas R & D Inc. (257836242)

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

Revised: 10/2022

Document Id: eb41afeb-5723-0d89-e053-2995a90a2e2f

34390-5

Set id: a8d5c422-a6a3-bcbe-e053-2995a90ab781

Version: 3

Effective Time: 20221017