ZEP APPLAUD AB- chloroxylenol liquid
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.

----------

66949-385 Applaud AB

Chloroxylenol 0.3%

Antiseptic

Uses

Hand washing to decrease bacteria on skin.

For external use only.

For external use only.

Do not use

Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

When using this product

Do not swallow.
If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.

Stop use ask a doctor if skin irritation or redness persists for more than 72 hours.

Keep out of reach of children except under adult supervision.

Directions

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

Other information

Store at room temperature.
Do not freeze.
Dispose in accordance with all applicable federal, state and local regulations.

Inactive ingredients

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

Questions or comments?

Call 1-877-BUY-ZEP (1-877-428-9937)

3385

ZEP APPLAUD AB
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66949-385
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)
POTASSIUM LAURATE (UNII: V4361R8N4Z)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE SODIUM (UNII: MP1J8420LU)
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66949-385-01	11400 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/10/2017	12/31/2020
2	NDC:66949-385-24	15140 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/10/2017	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/10/2017	12/31/2020

Labeler - Zep Inc. (030471374)

Name	Address	ID/FEI	Business Operations
Establishment
Zep Inc.		112125310	manufacture(66949-385)

Revised: 11/2020

Document Id: b46427ff-8e3e-7f8f-e053-2995a90a22bb

Set id: 5a92253f-a668-afe2-e053-2991aa0a90cd

Version: 4

Effective Time: 20201118

Zep Inc.