Your browser does not support JavaScript! ZEP APPLAUD HAND CLEANER (TRICLOSAN) SOAP [ZEP INC.]
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ZEP APPLAUD HAND CLEANER (triclosan) soap
[Zep Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredient

Chloroxylenol 0.2%

Triclosan 0.2%

Purpose

Antispetic

Uses

Hand washing to decrease bacteria on skin.

Warnings

For external use only.

Do not use in the eyes.

When using this product

  • if swallowed, seek medical attention.
  • if eye contact occurs, flush eyes with water and contact a physician.

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

Keep out of reach of children.

Directions

  • Wet hands with water.
  • Place hand under dispenser.
  • Apply liquid soap.
  • Massage soap into hands ans wrists, emphasizing back of hands, knuckles and cuticles.
  • Rinse thoroughly.

Other information

  • Store at room temperature
  • Do not freeze.

Inactive ingredients

Water, Potassium Tallate, Cocamide DIPA, Lauric Acid, Sodium Chloride, Alcohol, Tetrasodium EDTA, Acrylates/PEG-10 maleate/Styrene Copolymer, Triclosan, Fragrance, BHT, Red 4, Red 33, 

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ZEP APPLAUD HAND CLEANER 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66949-923
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL0.02 g  in 10 mL
TRICLOSAN (TRICLOSAN) TRICLOSAN0.02 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
TALL OIL 
POTASSIUM HYDROXIDE 
COCO DIISOPROPANOLAMIDE 
LAURIC ACID 
SODIUM CHLORIDE 
ALCOHOL 
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER 
BUTYLATED HYDROXYTOLUENE 
FD&C RED NO. 4 
D&C RED NO. 33 
Product Characteristics
Colorred, orangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66949-923-01946 mL in 1 BOTTLE, PLASTIC
2NDC:66949-923-243785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/26/2003
Labeler - Zep Inc. (030471374)
Establishment
NameAddressID/FEIBusiness Operations
Zep Inc.030471374manufacture(66949-923)

Revised: 12/2013
 
Zep Inc.

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