PRESTIGE- chloroxylenol soap

Prestige by

Drug Labeling and Warnings

Prestige by is a Otc medication manufactured, distributed, or labeled by Sunburst Chemicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 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, Green 3, Yellow 5

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRESTIGE 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63621-400
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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; 1600 KD) (UNII: 0L414VCS5Y)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63621-400-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/02/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/02/2014

Labeler - Sunburst Chemicals, Inc. (006159339)