Prestige

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 physician.

Not for use on children under 6 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 fifteen 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

Product Label - 1 gallon Short Neck Label

PRESTIGE
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63621-335
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)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE SODIUM (UNII: MP1J8420LU)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

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:63621-335-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	04/03/2020

Labeler - Sunburst Chemicals, Inc. (006159339)

Revised: 11/2023

Document Id: 0a5f32b4-43e5-7b27-e063-6394a90a4732

Set id: 2e4bb97c-9c16-43d1-aea3-54723c7afc45

Version: 3

Effective Time: 20231117

Sunburst Chemicals, Inc.