Active Ingredient(s)

Benzalkonium chloride 0.13% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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 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.

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

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, ethyl alcohol, lauryl glucoside, n-alkyl-n-dimethyl ammonium chloride, grapefruit seed extract.

PDP

1000 mL NDC: 77993-005-01 PDP 1000 ml

5000 mL NDC: 77993-005-02 PDP 5000 ml

20000 mL NDC: 77993-005-03 PDP 20000 ml

200000 mL NDC: 77993-005-04 PDP 200000 ml

ECOSOL HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77993-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
3-CHLORO-2-HYDROXYPROPYLCOCOALKYLDIMETHYLAMMONIUM CHLORIDE (UNII: 0V8LAK7MX8)	0.03 mL in 100 mL
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)	0.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)	98.89 mL in 100 mL
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)	0.03 mL in 100 mL
METHYL ALCOHOL (UNII: Y4S76JWI15)	0.47 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77993-005-01	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
2	NDC:77993-005-02	5000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020
3	NDC:77993-005-03	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:77993-005-04	200000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Ecosolutions, S. de R.L. de C.V. (814399275)

Registrant - Ecosolutions, S. de R.L. de C.V. (814399275)

Name	Address	ID/FEI	Business Operations
Establishment
Ecosolutions, S. de R.L. de C.V.		814399275	manufacture(77993-005) , pack(77993-005) , label(77993-005)

Hand sanitizer