ECOSOL HAND SANITIZER- benzalkonium chloride liquid

Ecosol Hand sanitizer by

Drug Labeling and Warnings

Ecosol Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Ecosolutions, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

PDP

1000 mL NDC: 77993-005-01

5000 mL NDC: 77993-005-02

20000 mL NDC: 77993-005-03

200000 mL NDC: 77993-005-04

INGREDIENTS AND APPEARANCE

ECOSOL HAND SANITIZER 
benzalkonium chloride liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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)

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