HAND SANITIZER- 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., GRUPO DE ZAVALETA S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antimicrobial

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

• in 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.

Keep the lid of this container tightly closed.

Inactive ingredients

Carpobol 90, T.E.A Triethanolamine, Glycerin

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)

Package Label - Principal Display Panel

60 mL NDC: 75778-005-60

118 mL NDC: 75778-005-11

236 mL NDC: 75778-005-23

473 mL NDC: 75778-005-47

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75778-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75778-005-60	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/19/2020
2	NDC: 75778-005-11	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/19/2020
3	NDC: 75778-005-23	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/19/2020
4	NDC: 75778-005-47	473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/19/2020

Labeler - Audy Global Enterprises Inc. (079171473)

Establishment
Name	Address	ID/FEI	Business Operations
GRUPO DE ZAVALETA S.A. DE C.V.		951577304	manufacture(75778-005)