PRESTIGE- chloroxylenol soap

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
21-03-2024

Wirkstoff:

CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)

Verfügbar ab:

Sunburst Chemicals, Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Skin Antimicrobial reduces amount of bacteria on hands

Berechtigungsstatus:

OTC monograph not final

Fachinformation

                                PRESTIGE- CHLOROXYLENOL SOAP
SUNBURST CHEMICALS, INC.
----------
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
PRESTIGE
chloroxylenol soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63621-335
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)
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
Sunburst Chemicals, Inc.
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:63621-
335-14
3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
04/03/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
505G(a)(3)
04/03/2020
LABELER -
Sunburst Chemicals, Inc. (006159339)
Revised: 3/2024
                                
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