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Antibacterial Hand by Henry Schein, Inc.

Dosage form: soap
Ingredients: chloroxylenol 6.10g in 1L
Labeler: Henry Schein, Inc.
NDC Code: 0404-4438

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%




For handwashing to decrease bacteria on skin. Recommended for repeated use.


For external use only.

When using this product
  • supervise children under 6
  • do not use in the eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask doctor if irritation or redness develop and persist for more than 72 hours.

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


Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

Inactive ingredients

aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle

Henry Schein



Cucumber & Aloe

Jabón de manos

Savon antibactérien
pour les mains

Distributed by:
Distribuido por: Distribué par:
135 Duryea Road
Melville, NY 11747 USA

16 fl. oz. • 473 ml

chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-4438
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chloroxylenol (chloroxylenol) chloroxylenol6.10 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
coco diethanolamide 
cocamidopropyl betaine 
diazolidinyl urea 
propylene glycol 
sodium chloride 
sodium laureth-3 sulfate 
edetate sodium 
.alpha.-tocopherol acetate 
#Item CodePackage Description
1NDC:0404-4438-010.473 L in 1 BOTTLE
2NDC:0404-4438-020.237 L in 1 BOTTLE
3NDC:0404-4438-033.785 L in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/30/2013
Labeler - Henry Schein, Inc. (012430880)
Registrant - Safetec of America, Inc. (874965262)
Safetec of America, Inc.874965262MANUFACTURE(0404-4438)

Revised: 01/2013
Henry Schein, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.