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.

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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

FULL PRESCRIBING INFORMATION: CONTENTS*

DOSAGE & ADMINISTRATION SECTION

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

FULL PRESCRIBING INFORMATION

DOSAGE & ADMINISTRATION SECTION

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PDP

STIPTIK 
ferric subsulfate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66915-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66915-301-04100 in 1 CARTON01/25/201812/31/2022
1NDC:66915-301-031 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/25/2018
Labeler - Island Kinetics, Inc. d.b.a. CoValence Laboratories (959735002)
Establishment
NameAddressID/FEIBusiness Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories959735002manufacture(66915-301)

Revised: 1/2022
Document Id: d4dd1b59-a4f7-6890-e053-2a95a90a2296
Set id: 62e8e595-0dcd-8918-e053-2a91aa0a4714
Version: 5
Effective Time: 20220105
 
Island Kinetics, Inc. d.b.a. CoValence Laboratories