Kerydin (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 10 mL Bottle Label

PharmaDerm®
NDC 10337-905-10

Kerydin®
(TAVABOROLE)
TOPICAL SOLUTION, 5%

For Topical Use Only 10 mL

Not for oral, ophthalmic, or intravaginal use

Rx only

PRINCIPAL DISPLAY PANEL -- 10 mL Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Bottle Carton

PharmaDerm®
NDC 10337-905-10

Kerydin®
(TAVABOROLE)
TOPICAL SOLUTION, 5%

For Topical Use Only

Not for oral, ophthalmic, or intravaginal use

10 mL

Rx only

PRINCIPAL DISPLAY PANEL -- 10 mL Bottle Carton
(click image for full-size original)
KERYDIN tavaborole solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10337-905
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAVABOROLE (TAVABOROLE) TAVABOROLE 43.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
PROPYLENE GLYCOL
EDETATE CALCIUM DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10337-905-10 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR
1 10 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (10337-905-10)
2 NDC:10337-905-44 1 BOTTLE, WITH APPLICATOR in 1 CARTON contains a BOTTLE, WITH APPLICATOR
2 4 mL in 1 BOTTLE, WITH APPLICATOR This package is contained within the CARTON (10337-905-44)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204427 07/07/2014
Labeler — PharmaDerm, A division of Fougera Pharmaceuticals Inc. (043838424)
Registrant — Pfizer Inc (113480771)

Revised: 08/2018 PharmaDerm, A division of Fougera Pharmaceuticals Inc.

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