ALCOHOL-FREE ANTISEPTIC GEL- benzalkonium chloride gel

Alcohol-Free Antiseptic Gel by

Drug Labeling and Warnings

Alcohol-Free Antiseptic Gel by is a Otc medication manufactured, distributed, or labeled by Bioagaves de la Costa, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria that can potencially cause disease.

For use when soap and water are not available.

WARNINGS

Do not freeze. For external use only.

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.

Directions

• Place just one drop on hands to cover all surfaces.

OTHER INFORMATION

• Store below 110F (43C)
• May discolor certain fabrics or surfaces

INACTIVE INGREDIENTS

Water, hyroxyethyl cellulose, glycerin, methylparaben, propylene glycol, DMDM H

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL-FREE ANTISEPTIC GEL 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76598-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76598-010-01	4 mL in 1 POUCH; Type 0: Not a Combination Product	04/24/2020
2	NDC: 76598-010-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
3	NDC: 76598-010-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
4	NDC: 76598-010-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
5	NDC: 76598-010-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
6	NDC: 76598-010-06	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
7	NDC: 76598-010-07	4500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020
8	NDC: 76598-010-08	20000 mL in 1 JUG; Type 0: Not a Combination Product	04/24/2020
9	NDC: 76598-010-09	200000 mL in 1 JUG; Type 0: Not a Combination Product	04/24/2020
10	NDC: 76598-010-10	1000000 mL in 1 JUG; Type 0: Not a Combination Product	04/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/24/2020

Labeler - Bioagaves de la Costa, S.A. de C.V. (814644548)

Establishment
Name	Address	ID/FEI	Business Operations
Bioagaves de la Costa, S.A. de C.V.		814644548	manufacture(76598-010)