MONSELS SOLUTION- ferric subsulfate paste

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Premier Dental Products Company

INN (Isem Internazzjonali):

FERRIC SUBSULFATE

Kompożizzjoni:

FERRIC CATION 210 mg in 1 g

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

unapproved drug other

Karatteristiċi tal-prodott

MONSELS SOLUTION- FERRIC SUBSULFATE PASTE
PREMIER DENTAL PRODUCTS COMPANY
_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._
----------
MONSELS
ACTIVE INGREDIENTS:
Ferric Subsulfate...20-22% by weight
Other ingredients include thickeners, preservatives and purified
water.
Do not reuse, discard after one use.
Store at room temperature (15-30°C).
Keep cap tightly sealed.
Protect from light.
Mfg. for and Dist. by:
Premier Medical Products
Plymouth Meeting, PA 19462
PRINCIPAL DISPLAY PANEL
Contains 8ml NDC 48783-112-08
Premier
Monsel's Ferric Subsulfate Solution
REF 9045055
12 single application 8ml bottles of Monsel's soution
and 12 rayon tip applicators
Rx ONLY Made in U.S.A.
GYNEX LABEL
Contains 8ml NDC 48783-112-08
Gynex
Monsel's Ferric Subsulfate Solution
REF 9045055
12 single application 8ml bottles of Monsel's soution
and 12 rayon tip applicators
Rx ONLY Made in U.S.A.
MONSELS SOLUTION
ferric subsulfate paste
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:48783-112
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
FERRIC SUBSULFATE (UNII: 3QJ8WS6V8H) (FERRIC CATION - UNII:91O4LML611)
FERRIC CATION
210 mg in 1 g
Premier Dental Products Company
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC SULFATE (UNII: 3HWS7HF5XD)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
yellow
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:48783-
112-08
14 g in 1 VIAL, SINGLE-DOSE; Type 0: Not a
Combination Product
06/10/2014
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
unapproved drug
other
06/10/2014
LABELER -
Premier Dental Products Company (014789663)
ESTABLISHMENT