ATALA BIO HAND SANITIZER- didecyldimonium chloride and benzalkonium chloride liquid gel

Atala Bio Hand Sanitizer by

Drug Labeling and Warnings

Atala Bio Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kemix Quimica, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

DIDECYLDIMONIUM CHLORIDE 0.25 % v/v. Purpose: Antiseptic

BENZALKONIUM CHLORIDE 0.1 % 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. Avoid Eye Contact.Flammable. Keep away from heat or flame. Do not ingest

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

glycerin, purified water USP, MAGNESIUM DISODIUM EDTA, ISOPROPYL ALCOHOL,METHYL ALCOHOL

Package Label - Principal Display Panel

4 L NDC: 77396-050-01

250 mL (0.25 L) NDC: 77396-050-03

75 mL (0.075 L) NDC: 77396-050-02

INGREDIENTS AND APPEARANCE

ATALA BIO HAND SANITIZER 
didecyldimonium chloride and benzalkonium chloride liquid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77396-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	2.5 mg  in 0.001 L
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 0.001 L

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL ALCOHOL (UNII: Y4S76JWI15)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77396-050-01	4 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2020
2	NDC: 77396-050-02	0.075 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2020
3	NDC: 77396-050-03	0.25 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - Kemix Quimica, S.A. de C.V. (813182128)

Registrant - Kemix Quimica, S.A. de C.V. (813182128)

Establishment
Name	Address	ID/FEI	Business Operations
Kemix Quimica, S.A. de C.V.		813182128	manufacture(77396-050) , label(77396-050)