Fluoroplex (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 30 g Tube Label

NDC 16110-812-30

30 grams

Fluoroplex ®
(fluorouracil) 1%
Topical Cream

RX ONLY

CONTAINS:
Active: fluorouracil 1.0% Inactives: benzyl alcohol; emulsifying wax; mineral oil; isopropyl myristate; sodium hydroxide; and purified water.

DOSAGE: Refer to accompanying literature for complete prescribing information.

Avoid freezing.

Store at 15° — 30°C (59° — 86°F).

SEE CRIMP FOR LOT NO. AND EXPIRATION DATE

Manufactured by: Almirall Hermal GmbH, 21465 Reinbek, Germany

Distributed by: Almirall, LLC, Exton, PA 19341, U.S.A.

Fluoroplex is a registered trademark of Almirall, LLC

ALMIRALL, LLC

30 g Tube Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 g Carton Label

NDC 16110-812-30

30 grams

Fluoroplex ®
(fluorouracil) 1%
Topical Cream

Contains:
Active: fluorouracil 1.0% Inactives: benzyl alcohol; emulsifying wax; mineral oil; isopropyl myristate; sodium hydroxide; and purified water.

Rx Only

Dosage: Refer to accompanying literature for complete prescribing information.

Avoid freezing.

Store at 15° — 30°C (59° — 86°F).

Manufactured by: Almirall Hermal GmbH, 21465 Reinbek, Germany

Distributed by: Almirall, LLC, Exton, PA 19341, U.S.A.

Fluoroplex is a registered trademark of Almirall, LLC

ALMIRALL, LLC

30 g Carton Label
(click image for full-size original)
FLUOROPLEX fluorouracil cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16110-812
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOROURACIL (FLUOROURACIL) FLUOROURACIL 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
ISOPROPYL MYRISTATE
MINERAL OIL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16110-812-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (16110-812-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016988 12/03/1993
Labeler — Almirall, LLC (605425912)

Revised: 03/2022 Almirall, LLC

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