ANTIBACTERIAL SKIN CLEANSER 82- chloroxylenol soap
Whisk Products, 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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Antibacterial Skin Cleanser #82

Active Ingredient

Chloroxylenol 1% w/w

Purpose

Health Care Personnel Hand Wash

Uses

Hand wash to help reduce bacteria that cause disease
Repeated usage suggested

Warnings

For external use only.

Avoid contact with eyes and mouth.

If redness or irritation develops, discontinue use immediately. If condition persists for more than 72 hours, consult a physician.

Not for use on children under 6 months of age.

Keep out of reach of children.

Directions

Wet hands and forearms.
Apply 5 mL of product to hands.
Scrub well for 30 seconds.
Rinse and repeat.

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

Cartridge Label

ANTIBACTERIAL SKIN CLEANSER 82
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65585-579
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 DIETHANOLAMINE (UNII: O4GQ19886U)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (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	Marketing End Date
Packaging
1	NDC:65585-579-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2016	07/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/20/2016	07/15/2021

Labeler - Whisk Products, Inc. (834270639)

Name	Address	ID/FEI	Business Operations
Establishment
Whisk Products, Inc.		834270639	manufacture(65585-579)

Revised: 12/2021

Document Id: f9f45b4e-cb64-4112-8593-218dd8b30101

Set id: 1379afb8-b90b-43f1-9272-58226c6027bb

Version: 2

Effective Time: 20211202

Whisk Products, Inc.