DERMACEN NON-ALCOHOL FOAMING HAND SANITIZER- benzalkonium chloride solution

DermaCen Non-Alcohol Foaming Hand Sanitizer by

Drug Labeling and Warnings

DermaCen Non-Alcohol Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Central Solutions Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.13%

INDICATIONS & USAGE

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

WARNINGS

Warnings

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

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

Keep out of reach of children. If swallowed, call a physician or Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

INACTIVE INGREDIENT

Inactive ingredients

Purified Water, Glycerin, Cocamidopropyl Betaine, Triethanolamine

PURPOSE

Purpose

Hand Sanitizer

PRINCIPAL DISPLAY PANEL

DermaCen

Non-Alcohol

Foaming Instant

Hand Sanitizer

For hand sanitizing

to decrease bacteria

on the skin

NET CONTENTS: 18 ounces (532 mL)

INGREDIENTS AND APPEARANCE

DERMACEN NON-ALCOHOL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62654-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62654-141-14	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/18/2010
2	NDC: 62654-141-16	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/18/2010
3	NDC: 62654-141-37	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/18/2010

Labeler - Central Solutions Inc (007118524)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions Inc		007118524	manufacture(62654-141)