DERMACEN ANTIMICROBIAL-B HAND- benzethonium chloride solution 
Central Solutions Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient:

Benzethonium Chloride 0.13%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on the skin.

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.

Directions

Apply to hands and wet as needed.

Lather vigorously for at least 15 seconds.

Wash skin, rinse thoroughly and dry.

Other information

Protect from freezing.Avoid excessive heat.

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

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?

Call 800-255-0262

DermaCen

Antimicrobial-B

Hand Soap

An antimicrobial

hand soap for healthcare

professionals to decrease

bacteria on the skin

Net Contents:

9 oz (266mL)

container label

DERMACEN ANTIMICROBIAL-B HAND 
benzethonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-232
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62654-232-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/09/2018
Labeler - Central Solutions Inc (007118524)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions Inc007118524manufacture(62654-232)

Revised: 4/2018
Document Id: 91b4a79d-2cce-4b04-b461-0cd9616a1a37
Set id: 4cf4aa1d-4a2e-4ab1-9f16-af1a8c136660
Version: 1
Effective Time: 20180409
 
Central Solutions Inc