STIPTIK ferric subsulfate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611)

Available from:

Island Kinetics, Inc. d.b.a. CoValence Laboratories

INN (International Name):

FERRIC SUBSULFATE

Composition:

FERRIC CATION 1 g in 1 g

Prescription type:

OTC DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

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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OTC # 301; STIPTIK SWAB (100)
ACTIVE INGREDIENT: Ferric Subsulfate (Monsel's Solution) 0.20-0.22 gm
Fe
PURPOSE: Astringent
Keep out of reach of children.
US ES :
Used as a styptic.
Stops bleeding caused by minor surface cuts and abrasions as may occur
during shaving.
INACTIVE INGREDIENTS: Nitrate, Ferrous Salts
DIRECTIONS: Break swabpoule and apply directly to minor cuts and
abrasions as needed.
WARNINGS: FOR EXTERNAL 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.
PRINCIPAL DISPLAY PANEL
STIPTIK
ferric subsulfate solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 9 15-30 1
ROUTE OF ADMINISTRATION
TOPICAL
Island Kinetics, Inc. d.b.a. CoValence Laboratories
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
FERRIC SUBSULFATE (UNII: 3QJ8 WS6 V8 H) (FERRIC CATION - UNII:9
1O4LML6 11)
FERRIC CATION
1 g in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WA TER (UNII: 0 59 QF0 KO0 R)
1 g in 1 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 6 9 15-30 1-0 2
10 0 in 1 CARTON
10 /14/20 14
1
NDC:6 6 9 15-30 1-0 1
1 g in 1 APPLICATOR; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
10 /14/20 14
LABELER -
Island Kinetics, Inc. d.b.a. CoValence Laboratories (959735002)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Island Kinetics, Inc. d.b.a. Co Valence Labo rato ries
9 59 7350 0 2
ma nufa c ture (6 6 9 15-30 1)
Revised: 6/2017