CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ), FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY), TERBINAFINE (UNII: G7RIW8S0XP) (TERBINAFINE - UNII:G7RIW8S0XP)

Disponible depuis:

Sincerus Florida, LLC

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

unapproved drug other

Résumé des caractéristiques du produit

CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%- CICLOPIROX 8% /
FLUCONAZOLE 1% / TERBINAFINE HCL 1% SOLUTION
SINCERUS FLORIDA, LLC
_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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CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%
DIRECTIONS FOR USE
SINCERUS FLORIDA, LLC ADVERSE REACTIONS.
ACTIVE, INACTIVE
NDC 72934-4045-9 CICLOPIROX OLAMINE USP 8% / FLUCONAZOLE USP 1% /
TERBINAFINE HCL USP 1%. SOLUTION 15GM
CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%
ciclopirox 8% / fluconazole 1% / terbinafine hcl 1% solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:729 34-40 45
ROUTE OF ADMINISTRATION
TOPICAL
Sincerus Florida, LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CICLO PIRO X (UNII: 19 W0 19 ZDRJ) (CICLOPIROX - UNII:19 W0 19 ZDRJ)
CICLOPIROX
8 g in 10 0 g
FLUCO NAZO LE (UNII: 8 VZV10 2JFY) (FLUCONAZOLE - UNII:8 VZV10 2JFY)
FLUCONAZOLE
1 g in 10 0 g
TERBINAFINE (UNII: G7RIW8 S0 XP) (TERBINAFINE - UNII:G7RIW8 S0 XP)
TERBINAFINE
1 g in 10 0 g
PRODUCT CHARACTERISTICS
COLOR
white (CLEAR SOLUTION)
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:729 34-40 45-9
15 g in 1 VIAL, GLASS; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 19
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
0 5/0 1/20 19
LABELER -
Sincerus Florida, LLC (080105003)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Sincerus Flo rida, LLC
0 8 0 10 50 0 3
ma nufa c ture (729 34-40 45)
Revised: 4/2019