0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER- hand sanitizer gel

0.13% Benzalkonium Chloride Instant Hand sanitizer by

Drug Labeling and Warnings

0.13% Benzalkonium Chloride Instant Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by BJ Goods LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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.

PURPOSE

Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

DOSAGE & ADMINISTRATION

Dosage form: Gel

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.

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13% v/v

WARNINGS

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 by signs o a serious condition.

INACTIVE INGREDIENT

Aloe, glycerin, sterile distilled water

PRINCIPAL DISPLAY PANEL

Anti-Bacterial Hand Sanitizer (Disinfectant Gel) free - alcohol

3.8L label NDC: 79635-019-05

PRINCIPAL DISPLAY PANEL

60 ml label NDC: 79635-019-01

100 ml label NDC: 79635-019-02

240 ml label NDC: 79635-019-03

500 ml label NDC: 79635-019-04

INGREDIENTS AND APPEARANCE

0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79635-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)	0.1 g  in 100 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)	0.1 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.09 g  in 100 mL
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)	0.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)	96.08 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	3 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79635-019-03	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020
2	NDC: 79635-019-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020
3	NDC: 79635-019-01	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020
4	NDC: 79635-019-05	3800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020
5	NDC: 79635-019-02	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/04/2020

Labeler - BJ Goods LLC (117585173)