Label: STIPTIK- ferric subsulfate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 66915-301-03, 66915-301-04 - Packager: Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 5, 2022
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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
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Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
DOSAGE & ADMINISTRATION SECTION
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- Sections or subsections omitted from the full prescribing information are not listed.
- DOSAGE & ADMINISTRATION SECTION
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INGREDIENTS AND APPEARANCE
STIPTIK
ferric subsulfate solutionProduct 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 Marketing End Date 1 NDC:66915-301-04 100 in 1 CARTON 01/25/2018 12/31/2022 1 NDC:66915-301-03 1 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/25/2018 Labeler - Island Kinetics, Inc. d.b.a. CoValence Laboratories (959735002) Establishment Name Address ID/FEI Business Operations Island Kinetics, Inc. d.b.a. CoValence Laboratories 959735002 manufacture(66915-301)
