CLEAN XPRESS ANTISEPTIC HAND CLEANER- chloroxylenol soap
Spartan Chemical Company, 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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Active Ingredient

Chloroxylenol 1% w/w

Purpose

Skin antimicrobial

Use

Reduces amount of bacteria on hands.

Warnings

For external use only. Do not use in eyes.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.
Not for use on children under six months of age.
For institutional and professional use only.

Directions

Wet hands and forearms.
Apply a small amount (5 mL) or palmful to hands and forearms.
Scrub thoroughly for at least 15 seconds.
Rinse completely and dry.

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

Questions?

1-800-537-8990

Package Label

Product Label

Case Label

CLEAN XPRESS ANTISEPTIC HAND CLEANER
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64009-338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	white (white, opaque liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64009-338-02	12 in 1 BOX	04/20/2020
1		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/20/2020

Labeler - Spartan Chemical Company, Inc. (005036728)

Revised: 1/2023

Document Id: f37d22aa-5abd-8f41-e053-2995a90a02ee

Set id: b0a70513-9530-4209-90c9-3cf2fd9895e5

Version: 5

Effective Time: 20230130

Spartan Chemical Company, Inc.