HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Audy Global Enterprises Inc., Ecodeli Comercial, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% v/v.

PURPOSE

Purpose: Antimicrobial

Use

Place product in a dispenser if desired

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

• on Children less than 2 months of age
• on open skin wounds

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

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.

Directions

• 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 information

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

Inactive ingredients

Water (Aqua) , Glycerin, Carbomer, Phenoxyethanol, Aminomethyl propanol

Package Label - Principal Display Panel

500 ml NDC: 75778-003-50

5 L NDC: 75778-003-55

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75778-003
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
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)	0.5 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	3 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75778-003-50	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75778-003-55	5000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/28/2020

Labeler - Audy Global Enterprises Inc. (079171473)

Establishment
Name	Address	ID/FEI	Business Operations
Ecodeli Comercial, S.A. de C.V.		588530951	manufacture(75778-003)