DERMACEN ANTIMICROBIAL-B HAND- benzethonium chloride solution

DermaCen Antimicrobial-B Hand by

Drug Labeling and Warnings

DermaCen Antimicrobial-B Hand 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:

Benzethonium Chloride 0.13%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

For handwashing to decrease bacteria on the skin.

WARNINGS

Warnings

For External Use Only.

Do not use in the eyes.

Discontinue use if irritation and redness develops.

If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Apply to hands and wet as needed.

Lather vigorously for at least 15 seconds.

Wash skin, rinse thoroughly and dry.

STORAGE AND HANDLING

Other information

Protect from freezing.Avoid excessive heat.

Store at 40-95 F (4-35 C)

INACTIVE INGREDIENT

Inactive Ingredients

Purified Water, Lauramine Oxide,Lauramidopropylamine Oxide, PEG-150 Distearate, Cocamide MEA, Glycerin, Cetrimonium Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Citric Acid, Yellow 5, Red 4, (may contain Sodium Hydroxide, Sodium Chloride).

QUESTIONS

Questions?

Call 800-255-0262

PRINCIPAL DISPLAY PANEL

DermaCen

Antimicrobial-B

Hand Soap

An antimicrobial

hand soap for healthcare

professionals to decrease

bacteria on the skin

Net Contents:

9 oz (266mL)

INGREDIENTS AND APPEARANCE

DERMACEN ANTIMICROBIAL-B HAND 
benzethonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62654-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62654-232-09	266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/09/2018

Labeler - Central Solutions Inc (007118524)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions Inc		007118524	manufacture(62654-232)