Ciclopirox Lotion

Name: Ciclopirox Lotion

Description

Ciclopirox Topical Suspension USP, 0.77% (Lotion) is for topical use.

Each gram of Ciclopirox Topical Suspension USP, 0.77% (Lotion) contains 7.7 mg of ciclopirox (as ciclopirox olamine) in a water miscible lotion base consisting of purified water USP, cocamide DEA, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as a preservative.

Ciclopirox Topical Suspension USP, 0.77% (Lotion) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2. The chemical structure is:

Ciclopirox Topical Suspension USP, 0.77% (Lotion) has a pH of 7.

Contraindications

Ciclopirox Topical Suspension USP, 0.77% (Lotion) is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

General: Ciclopirox Topical Suspension USP, 0.77% (Lotion) is not for ophthalmic use.

Keep out of reach of children.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 ML CONTAINER

NDC 0168-0314-30

Fougera®

CICLOPIROX
TOPICAL
SUSPENSION
USP 0.77%
(w/w) (LOTION)

Rx Only

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

Keep out of reach of children.
Bottle space provided to allow for
vigorous shaking before each use.

30 mL

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