HAND DEFENDER- alcohol gel

Hand Defender by

Drug Labeling and Warnings

Hand Defender by is a Otc medication manufactured, distributed, or labeled by Gm Integraciones y Soluciones en Control, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in children less than 2 months of age
• on open skin wounds

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

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

Purified Water, Glycerin, Carbopol, Triethanolamine

Product Label

INGREDIENTS AND APPEARANCE

HAND DEFENDER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77377-001
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77377-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
2	NDC: 77377-001-02	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
3	NDC: 77377-001-03	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
4	NDC: 77377-001-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
5	NDC: 77377-001-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
6	NDC: 77377-001-06	540 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
7	NDC: 77377-001-07	700 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
8	NDC: 77377-001-08	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
9	NDC: 77377-001-09	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
10	NDC: 77377-001-10	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
11	NDC: 77377-001-11	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
12	NDC: 77377-001-12	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
13	NDC: 77377-001-13	220000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
14	NDC: 77377-001-14	1000000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020
15	NDC: 77377-001-15	200000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/08/2020

Labeler - Gm Integraciones y Soluciones en Control, S.A. de C.V. (812758685)

Establishment
Name	Address	ID/FEI	Business Operations
Gm Integraciones y Soluciones en Control, S.A. de C.V.		812758685	manufacture(77377-001)