ANTIBACTERIAL HAND- benzalkonium chloride gel

Antibacterial Hand by

Drug Labeling and Warnings

Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by ORGANICA (UK) LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.1%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease

Recommended for repeated use.

WARNINGS

Warnings

For external use only.

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Pump a small amount of gel into the palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together until dry.

INACTIVE INGREDIENT

Inactive ingredients

Water, cetrimonium chloride, glycereth-2 cocoate, behentrimonium chloride, acrylates/diethylaminoethyl methacrylate copolymer, lactic acid, tetrasodium EDTA.

PRINCIPAL DISPLAY PANEL

ANTIBACTERIAL HAND GEL

CLEANS IN SECONDS

KILLS 99.9% of BACTERIA

FREE from ALCOHOL

CHLORINE, FRAGRANCE and DYES

5.07fl 0z

(150ml)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76268-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
LACTIC ACID (UNII: 33X04XA5AT)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76268-001-01	50 mL in 1 BOTTLE, PLASTIC
2	NDC: 76268-001-02	150 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/27/2011

Labeler - ORGANICA (UK) LTD (235330151)

Establishment
Name	Address	ID/FEI	Business Operations
ORGANICA (UK) LTD		235330151	manufacture