EFAS HAND SANITIZER- alcohol gel 
Efas Health Products, 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.

----------

Efas 70% 250, 500 mL, 1L and 1 Gal

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Do not use

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.

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

Directions

Other information

Inactive ingredients

Purified water USP, glycerin, carbomer and triethanolamine.

Package Label - Principal Display Panel

250 mL NDC: 74282-021-03 250

500 mL NDC: 74282-021-05 500

1000 mL NDC: 74282-021-07 1

3785 mL NDC: 74282-021-09 Gal

EFAS HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74282-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) 0.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E) 0.35 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74282-021-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
2NDC:74282-021-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
3NDC:74282-021-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
4NDC:74282-021-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/07/2020
Labeler - Efas Health Products, Inc. (117469301)

Revised: 7/2020
Document Id: aaebbe85-f816-2a3a-e053-2995a90ab2b7
Set id: a5f61e1a-4604-ba46-e053-2995a90a3b6e
Version: 3
Effective Time: 20200720
 
Efas Health Products, Inc.