ANTIMICROBIAL ANTISEPTIC HAND WASH - chloroxylenol soap 
PSS World Medical, 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.

----------

Antimicrobial Antiseptic Hand Wash 6620 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.5% w/w

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

For hand-washing to decrease bacteria on the skin

Antimicrobial hand cleanser

Recommended for repeated use

Drug Facts Box OTC-Warnings Section

For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Drug Facts Box OTC-When Using Section

Do not use in the eyes.

If contact occurs, rinse eyes thoroughly with water

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.


Drug Facts Box OTC-Keep Out of Reach of Children Section

If swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts Box OTC-Dosage & Administration Section

Wet hands and forearms

Apply 5ml (teaspoonful) or palmful to hands and forearms

Scrub thoroughly for 1 minute. Rinse and repeat.





Drug Facts Box OTC-General Precautions Section

Store at room temperature

Drug Facts Box OTC-Inactive Ingredient Section

Water, Decyl Glucoside, Sodium Laureth Sulfate, Cocamide DEA, Propylene Glycol, Glycol Distearate, Cocomide MEA, Laureth-10, Sodium Chloride, Citric Acid, Fragrance, Hexahydro-1,3,5,-tris(2-hydroxyethyl)-s-triazine, Direct Blue 86

Antimicrobial Antiseptic Hand Wash 6620 18oz

662018P6318.jpg  Antimicrobial Antiseptic Hand Wash 18ozimage of bottle label

ANTIMICROBIAL ANTISEPTIC HAND WASH 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68345-620-061 in 1 BOX
1800 mL in 1 BAG
2NDC:68345-620-17532 mL in 1 BOTTLE, PLASTIC
3NDC:68345-620-143785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33301/01/2010
Labeler - PSS World Medical, Inc. (101822682)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture

Revised: 3/2010
Document Id: 167249b8-6ea3-4429-bb39-ce706cc5a5ae
Set id: 6c611ff0-b08c-46ae-bdb3-a0eeb582fb60
Version: 1
Effective Time: 20100322
 
PSS World Medical, Inc.