HAND SANITIZER- alcohol gel 
Audy Global Enterprises 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.

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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

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.

Keep the lid of this container tightly closed.

Inactive ingredients

Carpobol 90, T.E.A Triethanolamine, Glycerin

Directions

Other information

Package Label - Principal Display Panel

60 mL NDC:75778-005-60

60mL

118 mL NDC:75778-005-11

118mL

236 mL NDC:75778-005-23

236 mL

473 mL NDC:75778-005-47

473mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75778-005
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75778-005-6060 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
2NDC:75778-005-11118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
3NDC:75778-005-23236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
4NDC:75778-005-47473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/19/2020
Labeler - Audy Global Enterprises Inc. (079171473)
Establishment
NameAddressID/FEIBusiness Operations
GRUPO DE ZAVALETA S.A. DE C.V.951577304manufacture(75778-005)

Revised: 6/2020
Document Id: a8777e00-d03c-d55a-e053-2a95a90a14eb
Set id: a8779b2a-0214-ad02-e053-2a95a90a8b27
Version: 1
Effective Time: 20200619
 
Audy Global Enterprises Inc.