Rx Item-Naftifine 1% Cream 60Gm By Taro Pharma Gen Naftin

Clinical Information
Gen. Code and Des.
7374 naftifine HCl TOPICAL CREAM (G) 1 %
GCN and Des.
47770 naftifine HCl TOPICAL CREAM (G) 1 %
Strength
1%
Dose Form
CREAM (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
84040804 ALLYLAMINES (SKIN AND MUCOUS MEMBRANE)
Active Ingredients
2930 naftifine HCl 65473145
Inactive Ingredients
3192 benzyl alcohol 100516
7543 sorbitan esters









NAFTIN- naftifine hydrochloride cream
Merz Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

? NAFTIN Cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.

2 DOSAGE AND ADMINISTRATION

For topical use only. NAFTIN Cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of NAFTIN Cream once-daily to the affected areas plus a � inch margin of healthy surrounding skin for 2 weeks.

3 DOSAGE FORMS AND STRENGTHS



Each gram of NAFTIN Cream contains 20 mg of naftifine hydrochloride (2%) in a white to off-white base.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Local Adverse Reactions
Discontinue treatment if irritation or sensitivity develops with the use of NAFTIN Cream. Direct patients to contact their physician if these conditions develop following use of NAFTIN Cream.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. DESCRIPTION

NAFTIN Cream is a white to off-white cream for topical use only. Each gram of (naftifine hydrochloride) Cream contains 20 mg of naftifine hydrochloride (2%), a synthetic allylamine antifungal compound.

Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride.

The molecular formula is C21 H21 N�HCl with a molecular weight of 323.86. NAFTIN Cream contains the following inactive ingredients: benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, and hydrochloric acid.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
NAFTIN Cream is a topical antifungal drug [see Clinical Pharmacology(12.4)]

12.2 Pharmacodynamics
The pharmacodynamics of NAFTIN Cream have not been established.

RX ITEM-Naftifine 1% Cream 60Gm By Taro
Item No.:RX605766 NDC No.5167213623 51672136203 51672-1362-03 51672-1362-3 NDC No. 51672-1362-03 UPC/GTIN No. 3-51672-13623-9 351672-136239 351672136239 MPN 36203

Naftifine 1% Cream 60Gm By Taro Pharma
Item No.:RX605766 NDC No.5167213623 51672136203 51672-1362-03 51672-1362-3 NDC No. 51672-1362-03 UPC/GTIN No. 3-51672-13623-9 351672-136239 351672136239 MPN 36203

NAFTIFINE HCL TOPICAL CRE
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