Zep Round One Hand Cleaner by Zep Inc. Zep Round One Hand Soap

Zep Round One Hand Cleaner by

Drug Labeling and Warnings

Zep Round One Hand Cleaner by is a Otc medication manufactured, distributed, or labeled by Zep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZEP ROUND ONE HAND CLEANER- 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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Zep Round One Hand Soap

Active ingredient

Chloroxylenol 0.4%

Purpose

Anitiseptic Handwash

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 develop.
• If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children.

Directions

• Wet hands with water.
• 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.

Inactive ingredients

Water, Sodium C14-16 Olefin Sulfonate, Polyethylene, Cocamidopropyl Betaine, Stearic Acid, C11-13 Pareth-6, Styrene/Acrylates Copolymer, Attapulgite, PEG-75 Lanolin, Glutaral, Methylchloroisothiazolinone (and) Methylisothiazolinone, Fragrance, Orange 4, Yellow 5

ZEP ROUND ONE HAND CLEANER 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66949-939
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.04 g  in 10 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
STEARIC ACID (UNII: 4ELV7Z65AP)
C11-13 PARETH-6 (UNII: G892LZ1790)
ATTAPULGITE (UNII: U6V729APAM)
PEG-75 LANOLIN (UNII: 09179OX7TB)
GLUTARAL (UNII: T3C89M417N)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66949-939-24	3.785 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/1988	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/1988	01/01/2020

Labeler - Zep Inc. (030471374)

Establishment
Name	Address	ID/FEI	Business Operations
Zep Inc.		030471374	manufacture(66949-939)

Revised: 9/2017

Document Id: 5a09372a-81b9-8493-e053-2991aa0af9c8

34390-5

Set id: a87d2c54-52e2-426e-a04e-ac1fdcf6cdbf

Version: 6

Effective Time: 20170925