ZEP ROUND ONE 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.

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66949-309 Round One AB

Chloroxylenol 0.4%

Antiseptic Handwash

Uses

Hand washing to decrease bacteria on skin

For external use only.

Do not use in or around the eyes.

When using this product

  • If eye contact occurs, rinse promptly and thoroughly with water.
  • 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 and 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 and apply liquid soap.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.
  • Rinse hands thoroughly and dry.

  • Do not freeze.
  • Dispose in accordance with all applicable federal, state and local regulations.

Water, Sodium C14-16 Olefin Sulfonate, Pumice, Cocamidopropyl Hydroxysultaine, Stearic Acid, Methacrylic Acid Copolymer, Attapulgite, C11-13 Pareth-6, PEG-75 Lanolin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Glutaral, Titanium Dioxide, Palmitostearic Acid, Orange 7, Yellow 5

Questions or comments?

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

Round One

ZEP ROUND ONE AB 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66949-309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PALMITOSTEARIC ACID (UNII: Q8Y7S3B85M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
PUMICE (UNII: NT5NN5KL16)  
ATTAPULGITE (UNII: U6V729APAM)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
GLUTARAL (UNII: T3C89M417N)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
DIPOTASSIUM 4',5'-DIBROMOFLUORESCEIN (UNII: 3T0760MA5A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
C11-13 PARETH-6 (UNII: G892LZ1790)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66949-309-243785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/19/201712/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/19/201712/31/2020
Labeler - Zep Inc. (030471374)
Establishment
NameAddressID/FEIBusiness Operations
Zep Inc.112125310manufacture(66949-309)

Revised: 11/2020
 
Zep Inc.