HAND DEFENDER- alcohol gel 
Gm Integraciones y Soluciones en Control, S.A. de C.V.

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

Alcohol 70% v/v.

Purpose

Antiseptic

Uses

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.

Directions

Other information

Inactive ingredients

Purified Water, Glycerin, Carbopol, Triethanolamine

Product Label

image description

image description

HAND DEFENDER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77377-001
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
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77377-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
2NDC:77377-001-02120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
3NDC:77377-001-03125 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
4NDC:77377-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
5NDC:77377-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
6NDC:77377-001-06540 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
7NDC:77377-001-07700 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
8NDC:77377-001-08750 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
9NDC:77377-001-091000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
10NDC:77377-001-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
11NDC:77377-001-1110000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
12NDC:77377-001-1220000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
13NDC:77377-001-13220000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
14NDC:77377-001-141000000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
15NDC:77377-001-15200000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/08/2020
Labeler - Gm Integraciones y Soluciones en Control, S.A. de C.V. (812758685)
Establishment
NameAddressID/FEIBusiness Operations
Gm Integraciones y Soluciones en Control, S.A. de C.V.812758685manufacture(77377-001)

Revised: 5/2020
Document Id: a13cfa56-ad4f-43a1-b66a-e683d08b0968
Set id: 95bf2263-4e89-45ff-9c5c-24c89bf38e14
Version: 1
Effective Time: 20200508
 
Gm Integraciones y Soluciones en Control, S.A. de C.V.