ANTIBACTERIAL HAND- 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

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

Warnings

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.

Directions

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

Antibacterial

HAND SOAP

Cucumber & Aloe

Jabón de manos
antibacteriano

Savon antibactérien
pour les mains

Distributed by:
Distribuido por: Distribué par:
HENRY SCHEIN, Inc.
135 Duryea Road
Melville, NY 11747 USA

16 fl. oz. • 473 ml

PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle
ANTIBACTERIAL HAND 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
water 
sodium chloride 
sodium laureth-3 sulfate 
edetate sodium 
.alpha.-tocopherol acetate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(0404-4438)

Revised: 1/2013
Document Id: 8d0f604a-b9ef-4c01-85c3-5f7d6d93528e
Set id: b108cec8-c2f8-4fcf-b317-90c51469da45
Version: 1
Effective Time: 20130130
 
Henry Schein, Inc.