ANTIFUNGAL- miconazole nitrate cream

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by McKesson, Central Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Miconazole Nitrate 2%

PURPOSE

Purpose

Antifungal

INDICATIONS & USAGE

Uses

Treats most jock itch, ringworm and athlete’s foot

WARNINGS

WarningsDo not use

• on children under 2 years of age
• for diaper rash. For external use only.

Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4
weeks for athlete’s foot or ringworm, or within 2 weeks
for jock itch, discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Clean the affected area and dry thoroughly.
• Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician.
• Supervise children in the use of this product.

Athlete’s foot

• Pay special attention to the spaces between toes
• wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete’s foot and ringworm

• use daily for 4 weeks

Jock Itch

• use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp or nails.

STORAGE AND HANDLING

Other information Store at 59-86ºF (15-30ºC).

INACTIVE INGREDIENT

Inactive ingredients Purified Water, Isopropyl Palmitate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Cetearyl Alcohol,
Cyclopentasiloxane, Propylene Glycol, Polyquaternium-37, Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf
Juice, DMDM Hydantoin, Iodopropynyl Butylcarbamate, (may contain Lactic Acid).

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Questions? Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

McKesson

Antifungal Cream

2% Miconazole Nitrate

Relieves itching, cracking, scaling and discomfort associated with most jock itch, ringworm and athlete’s foot.

Net Contents

4 fl oz

(118.3mL)

MFR# 53-6391

INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-1470
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
ALOE (UNII: V5VD430YW9)
DMDM HYDANTOIN (UNII: BYR0546TOW)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCINE (UNII: TE7660XO1C)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-1470-4	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/26/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/26/2017

Labeler - McKesson (023904428)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions		007118524	manufacture(68599-1470)