Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
Sunburst Chemicals, Inc.
TOPICAL
OTC DRUG
Skin Antimicrobial reduces amount of bacteria on hands
OTC monograph not final
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 Lesen Sie das vollständige Dokument