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NDC 70000-0340-01 Miconazole Nitrate Cream USP, 2% 2 g/100g Details

Miconazole Nitrate Cream USP, 2% 2 g/100g

Miconazole Nitrate Cream USP, 2% is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is MICONAZOLE NITRATE.

MedlinePlus Drug Summary

Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your condition.

Related Packages: 70000-0340-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Topical

Product Information

NDC	70000-0340
Product ID	70000-0340_edc1fb09-9f35-8bdf-e053-2995a90a7977
Associated GPIs	90154050103705
GCN Sequence Number	007366
GCN Sequence Number Description	miconazole nitrate CREAM (G) 2 % TOPICAL
HIC3	Q5F
HIC3 Description	TOPICAL ANTIFUNGALS
GCN	30400
HICL Sequence Number	003031
HICL Sequence Number Description	MICONAZOLE NITRATE
Brand/Generic	Generic
Proprietary Name	Miconazole Nitrate Cream USP, 2%
Proprietary Name Suffix	n/a
Non-Proprietary Name	Miconazole Nitrate Cream USP, 2%
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/100g
Substance Name	MICONAZOLE NITRATE
Labeler Name	Cardinal Health
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0340-01 (70000034001)

Pricing Information
NDC Package Code	70000-0340-1
Billing NDC	70000034001
Package	28.4 g in 1 TUBE (70000-0340-1)
Marketing Start Date	2018-07-30
NDC Exclude Flag	N
Price Per Unit	0.11539
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	MICONAZOLE 2% TOPICAL CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 776ca76a-a6cc-5238-e053-2a91aa0abfcb Details

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor
for diaper rash

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 2 weeks when used for the treatment of jock itch
there is no improvement within 4 weeks when used for athlete's foot or ringworm

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

Clean the affected area and dry thoroughly
Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
Supervise children in the use of this product
For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
For athlete's foot and ringworm, use daily for 4 weeks
For jock itch, use daily for 2 weeks
If condition persists longer, consult a doctor
This product is not effective on the scalp or nails

Other Information

Store at 15° -30°C (59° -86°F)

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Disodium Hydrogen Phosphate Dihydrate, Light Liquid Paraffin, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Dihydrogen Phosphate Dihydrate, White Soft Paraffin

Questions

1-888-DYNAREX

Label

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE CREAM USP, 2%

miconazole nitrate cream usp, 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0340
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0340-1	28.4 g in 1 TUBE; Type 0: Not a Combination Product	07/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	07/30/2018

Labeler - Cardinal Health (063997360)

Registrant - Dynarex Corporation (008124539)

Revised: 11/2022

Document Id: edc1fb09-9f35-8bdf-e053-2995a90a7977

Set id: 776ca76a-a6cc-5238-e053-2a91aa0abfcb

Version: 7

Effective Time: 20221118