ANTIMICROBIAL HAND WASH- chloroxylenol soap 
Henry Schein, 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.

----------

Drug Facts

Active Ingredient

Chloroxylenol (PCMX) 0.6%

Purpose

Antiseptic

Uses

Warnings

For external use only.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask doctor if

  • irritation and redness develops and 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

Directions

Inactive Ingredients

aloe vera, cocamide DEA, cocamidopropyl betaine, D&C Red #33, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA
Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

Henry Schein

112-5990

Maxiclens

Antimicrobial Hand Wash

NDC 0404-5990-01

27.05 FL. OZ. (800 ML)

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label
ANTIMICROBIAL HAND WASH 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-5990
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol6.0 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
coco diethanolamide (UNII: 92005F972D)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium chloride (UNII: 451W47IQ8X)  
sodium laureth sulfate (UNII: BPV390UAP0)  
edetate sodium (UNII: MP1J8420LU)  
alpha-tocopherol acetate (UNII: 9E8X80D2L0)  
propylparaben (UNII: Z8IX2SC1OH)  
methylparaben (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-5990-01800 mL in 1 BOX; Type 0: Not a Combination Product03/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/2012
Labeler - Henry Schein, Inc. (012430880)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(0404-5990)

Revised: 7/2016
Document Id: 2175033d-2201-4e33-86ee-600fac438d58
Set id: 5847a304-ff8e-4ae1-8bf0-ee7e6efb9451
Version: 2
Effective Time: 20160729
 
Henry Schein, Inc.