OTC Medication Information: ZEP ROUND ONE AB

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.

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
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ZEP ROUND ONE AB
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66949-309
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
PALMITOSTEARIC ACID
METHYLISOTHIAZOLINONE
WATER
SODIUM C14-16 OLEFIN SULFONATE
PUMICE
ATTAPULGITE
PEG-75 LANOLIN
METHYLCHLOROISOTHIAZOLINONE
GLUTARAL
COCAMIDOPROPYL HYDROXYSULTAINE
DIPOTASSIUM 4′,5′-DIBROMOFLUORESCEIN
FD&C YELLOW NO. 5
STEARIC ACID
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
C11-13 PARETH-6
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66949-309-24 3785 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/19/2017 12/31/2020
Labeler — Zep Inc. (030471374)
Establishment
Name Address ID/FEI Operations
Zep Inc. 112125310 manufacture (66949-309)

Revised: 11/2020 Zep Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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