ZEP APPLAUD HAND CLEANER- chloroxylenol and triclosan soap 
Zep 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.

----------

Zep Applaud Lotion Hand Soap

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

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

Other information

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, 

0923.jpg

ZEP APPLAUD HAND CLEANER 
triclosan soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66949-923
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.02 g  in 10 mL
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.02 g  in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
TALL OIL (UNII: 1GX6Z36A79)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
LAURIC ACID (UNII: 1160N9NU9U)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALCOHOL (UNII: 3K9958V90M)  
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
Color red, orange Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66949-923-01 946 mL in 1 BOTTLE, PLASTIC
2 NDC:66949-923-24 3785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 02/26/2003
Labeler - Zep Inc. (030471374)
Establishment
Name Address ID/FEI Business Operations
Zep Inc. 030471374 manufacture(66949-923)

Revised: 12/2013
Document Id: 7a353229-49b2-4638-aef7-197b7db4246f
Set id: 8ebee91f-0d69-44a0-a638-27cf23a207d8
Version: 3
Effective Time: 20131204
 
Zep Inc.