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%




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

PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle
chloroxylenol soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-4438
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol 6.10 g  in 1 L
Inactive Ingredients
Ingredient Name Strength
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-3 sulfate (UNII: BPV390UAP0)  
edetate sodium (UNII: MP1J8420LU)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0404-4438-01 0.473 L in 1 BOTTLE
2 NDC:0404-4438-02 0.237 L in 1 BOTTLE
3 NDC:0404-4438-03 3.785 L in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/30/2013
Labeler - Henry Schein, Inc. (012430880)
Registrant - Safetec of America, Inc. (874965262)
Name Address ID/FEI Business Operations
Safetec of America, Inc. 874965262 MANUFACTURE(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.