País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611)
Island Kinetics, Inc. d.b.a. CoValence Laboratories
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
STIPTIK- FERRIC SUBSULFATE SOLUTION ISLAND KINETICS, INC. D.B.A. COVALENCE LABORATORIES _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION OTC #301; STIPTIK SWAB (100) THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SEE FULL PRESCRIBING INFORMATION FOR INITIAL U.S. APPROVAL. DOSAGE AND ADMINISTRATION ACTIVE INGREDIENTS: Ferric Subsulfate (Monsel's Solution) 0.20 - 0.22 gm Fe (1) PURPOSE: Hemostatic Agent (1) USES: (1) Used as a styptic. Single use dose. Do not resuse. Stops local bleeding cause by minor surface cuts and abrasions. This proudct is intended for topical use only. WARNINGS: FOR EXERNAL USE ONLY. AVOID CONTACT WITH THE EYES. STOP USE AND ASK A DOCTOR if rash occurs. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. (1) DIRECTIONS: Break swabpoule and apply directly to minor cuts and abraisons as needed. (1) INGREDIENTS: Aqua (Water), Ferric Subsulfate (1) OTHER INFORMATION: Crystallization may occur if the product is exposed to temperatures below 22° C (70° F). Warming will re-dissolve the crystals. (1) NDC: 66915-301-04 (1) REVISED: 1/2018 FULL PRESCRIBING INFORMATION: CONTENTS* DOSAGE & ADMINISTRATION SECTION * FULL PRESCRIBING INFORMATION DOSAGE & ADMINISTRATION SECTION PRINCIPAL DISPLAY PANEL Sections or subsections omitted from the full prescribing information are not listed. STIPTIK ferric subsulfate solution PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:66915-301 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 1 g in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETI Llegiu el document complet