HAND SANITIZER- benzalkonium chloride lotion

hand sanitizer by

Drug Labeling and Warnings

hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Humphreyline. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

benzalkonium chloride (0.13%)

PURPOSE

antimicrobial

INDICATIONS & USAGE

Hand sanitizer to help reduce bacteria on the skin

WARNINGS

For external use only

Do not use in or near the eyes

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away

DOSAGE & ADMINISTRATION

Wet hands thoroughly with product and allow to dry without wiping

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

INACTIVE INGREDIENT

Water, cetearyl alcohol, petrolatum, behenamidopropyl dimethylamine lactate, lauryl laurate, glycerin, glycereth-2-cocoate, dimethicone, benzoic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 19392-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)
BEHENAMIDOPROPYL DIMETHYLAMINE BEHENATE (UNII: 96T33VV28E)
LAURYL LAURATE (UNII: GPW77G0937)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
DIMETHICONE (UNII: 92RU3N3Y1O)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 19392-500-02	15 g in 1 BOTTLE, PLASTIC
2	NDC: 19392-500-03	30 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2014

Labeler - Humphreyline (122539042)

Establishment
Name	Address	ID/FEI	Business Operations
Humphreyline		122539042	pack(19392-500)