Prestige

Manufacturer: Sunburst Chemicals, Inc.
Effective date: 2020-05-01
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:33:01

Label at a glance#

ProductPrestige

Active ingredientCHLOROXYLENOL

Label structure7 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 1% w/w

Purpose

OTC - PURPOSE SECTION

Skin Antimicrobial

Use

INDICATIONS & USAGE SECTION

Reduces amount of bacteria on hands

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Label - 1 Gallon

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLOROXYLENOL	ACTIVE INGREDIENT	0F32U78V2Q	1
CHLOROXYLENOL	ACTIVE MOIETY	0F32U78V2Q	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	1
LAURIC DIETHANOLAMIDE	INACTIVE INGREDIENT	I29I2VHG38	1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)	INACTIVE INGREDIENT	0L414VCS5Y	1
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Prestige
Chloroxylenol
WATER
SODIUM C14-16 OLEFIN SULFONATE
SODIUM LAURETH SULFATE
LAURIC DIETHANOLAMIDE
ISOPROPYL ALCOHOL
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)
EDETATE SODIUM
CITRIC ACID MONOHYDRATE
FD&C GREEN NO. 3
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63621-400	63621-400-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHLOROXYLENOL	0F32U78V2Q	ACTIB
WATER	059QF0KO0R	IACT
SODIUM C14-16 OLEFIN SULFONATE	O9W3D3YF5U	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
LAURIC DIETHANOLAMIDE	I29I2VHG38	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)	0L414VCS5Y	IACT
EDETATE SODIUM	MP1J8420LU	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 158 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	LOTION / TOPICAL	0.6 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	TABLET / ORAL	5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SHAMPOO / TOPICAL	0.09 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	CAPSULE / ORAL	1 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SYRUP / ORAL	0.1 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAVENOUS	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CAPSULE / ORAL	3.5 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, CHEWABLE / ORAL	4.5 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 22 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	SHAMPOO, SUSPENSION / TOPICAL	4 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	TABLET / ORAL	0.91 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	SUSPENSION / TOPICAL	0.48 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM LAURETH SULFATE	SODIUM LAURETH-3 SULFATE	BPV390UAP0	SHAMPOO / TOPICAL		3192 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	ELIXIR / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
LAURIC DIETHANOLAMIDE	LAURIC DIETHANOLAMIDE	I29I2VHG38	SHAMPOO / TOPICAL	20 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAMUSCULAR	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, EXTENDED RELEASE / ORAL	0.16 mg		Exact identifier — unii candidate 15 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9b44ad70-06c0-4634-b8d2-9329640244ec			7ce1ad4b-82e3-42e5-8317-0aefc97509ac	2020-05-01	Warnings	Exact identifier spl id: 9b44ad70-06c0-4634-b8d2-9329640244ec spl set id: 7ce1ad4b-82e3-42e5-8317-0aefc97509ac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.