MICONAZOLE NITRATE- antifungal cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)
Available from:
McKesson
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antifungal Uses Treats most jock itch, ringworm and athlete’s foot Consult a Doctor 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.
Authorization status:
OTC monograph final
Authorization number:
68599-1471-4

MICONAZOLE NITRATE- antifungal cream

McKes s on

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antifungal

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Treats most jock itch, ringworm and athlete’s foot

Warnings

Do not use

on children under 2 years of age

for diaper rash.

For external use only.

Avoid contact with eyes.

Consult a Doctor

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other Information

This product is not effective on scalp or nails.

Store at 59-86ºF (15-30ºC).

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol,

Dimethicone,

DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl

Butylcarbamate,

Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).

NDC 68599-1471-4

McKesson

Antifungal Cream 2%

MICONAZOLE

NITRATE

Relieves itching, cracking, scaling and

discomfort associated with most jock itch,

ringworm and athlete’s foot.

4 fl oz

(118.3 mL)

MFR # 53-6391

MICONAZOLE NITRATE

antifungal cream

McKesson

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 59 9 -1471

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MICO NAZO LE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0 D7S5M)

MICONAZOLE NITRATE

10 0 mg in 2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CARBO MER CO PO LYMER TYPE A ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 71DD5V9 9 5L)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 59 9 -1471-4

118 mg in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 7/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

0 7/25/20 19

Labeler -

McKesson (023904428)

Revised: 7/2019

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