STIPTIK- ferric subsulfate solution

Stiptik by

Drug Labeling and Warnings

Stiptik by is a Prescription medication manufactured, distributed, or labeled by Island Kinetics, Inc. d.b.a. CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• 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

• Table of Contents

  FULL PRESCRIBING INFORMATION: CONTENTS*

  DOSAGE & ADMINISTRATION SECTION
  
  

  * Sections or subsections omitted from the full prescribing information are not listed.

DOSAGE & ADMINISTRATION SECTION

Principal Display Panel

INGREDIENTS AND APPEARANCE

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	Marketing End Date
1	NDC: 66915-301-04	100 in 1 CARTON	01/25/2018
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)