HAND SANITIZER- benzalkonium chloride gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BLUE CROSS LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.12%. Purpose: Antibacterial

Purpose

Antibacterial, Hand Sanitizer

Use

• to decrease bacteria on the skin that could cause disease
• recommended for repeated use

Warnings

For external use only - hands

WHEN USING

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• do not inhale or ingest

Stop use and ask a doctor

if skin irritation develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6, use only under adult supervision
• not recommended for infants

Inactive ingredients

Water, glycerin, propylene glycol, Aloe barbadensis leaf extract, tocopheryl acetate, fragrance, triethanolamine, carbomer

Package Label - Principal Display Panel

89 mL NDC: 22431-150-01

236 mL NDC: 22431-150-02

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22431-150(NDC: 75729-002)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22431-150-01	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/09/2020
2	NDC: 22431-150-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/09/2020

Labeler - BLUE CROSS LABORATORIES (008298879)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Yaohu Bio-technology Co.ltd		404087605	manufacture(22431-150) , relabel(22431-150)