ANTIBACTERIAL SOAP - chloroxylenol gel 
Sanihealth Products Corporation

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.

----------

Antibacterial Soap

Directions:

Wet hands and forearms. Apply a small amount (approx. 5 ml) to hands and scrub thoroughly. Rinse well and dry.

Inactive Ingredients:

Water (aqua) sodium laureth sulfate, cocamidopropyl betaine, decyl glucoside, Cocamide DEA, sodium chloride, glycerin, fragrance, citric acid, DMDM hydantoin, Yellow 5, Red 4

Use:

For handwashing to decrease bacteria on the skin.

Active Ingredient                  Purpose

Chloroxylenol 0.5%               Antiseptic

Warnings:

For external use only.

Keep out of reach of children.

Avoid eye contact. Should contact occur, rinse thoroughly with water.

If swallowed or irritation develops, discontinue use and consult a health care practitioner.


label

Antibacterial gel Soap

Chloroxylenol 0.5%

800 ml (27 US fl oz)

ANTIBACTERIAL SOAP 
chloroxylenol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51053-502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol4 mL  in 800 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51053-502-081 in 1 BOX
1800 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2010
Labeler - Sanihealth Products Corporation (244200478)

Revised: 5/2010
Document Id: 3231512f-c1f6-4f9f-ba51-77f54c416683
Set id: cc5b3cfd-c2b0-430e-be0d-c8dc9e3e07d9
Version: 1
Effective Time: 20100510
 
Sanihealth Products Corporation