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NDC 70518-2338-00 Miconazole Nitrate 20 mg/g Details

Miconazole Nitrate 20 mg/g

Miconazole Nitrate is a VAGINAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is MICONAZOLE NITRATE.

MedlinePlus Drug Summary

Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Related Packages: 70518-2338-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Vaginal

Product Information

NDC	70518-2338
Product ID	70518-2338_e3a16c44-85d8-d5d8-e053-2a95a90a1aa2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Miconazole Nitrate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Miconazole Nitrate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	VAGINAL
Active Ingredient Strength	20
Active Ingredient Units	mg/g
Substance Name	MICONAZOLE NITRATE
Labeler Name	REMEDYREPACK INC.
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA074444
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-2338-00 (70518233800)

Pricing Information	N/A
NDC Package Code	70518-2338-0
Billing NDC	70518233800
Package	1 TUBE, WITH APPLICATOR in 1 CARTON (70518-2338-0) / 45 g in 1 TUBE, WITH APPLICATOR
Marketing Start Date	2019-10-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1f9efbcb-4b95-49df-95dc-093908c12e44 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Miconazole nitrate USP 2% (100 mg in each applicatorful)

Purpose

Vaginal antifungal

Uses

treats vaginal yeast infections
relieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time
lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
do not have vaginal intercourse
mild increase in vaginal burning, itching or irritation may occur
if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days
symptoms last more than 7 days
you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

before using this product read the enclosed consumer information leaflet for complete directions and information
adults and children 12 years of age and over:
- applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
- use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.
children under 12 years of age: ask a doctor

Other information

do not purchase if carton is opened
do not use if seal over tube opening has been punctured or is not visible
store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.

Questions?

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Miconazole Nitrate

GENERIC: Miconazole Nitrate

DOSAGE: CREAM

ADMINSTRATION: VAGINAL

NDC: 70518-2338-0

PACKAGING: 45 g in 1 TUBE, WITH APPLICATOR

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

Miconazole Nitrate 20mg in 1g

INACTIVE INGREDIENT(S):

Butylated Hydroxytoluene
Mineral Oil
Water
Benzoic Acid

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE

miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2338(NDC:51672-2035)
Route of Administration	VAGINAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-2338-0	1 in 1 CARTON	10/02/2019
1		45 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074444	10/02/2019

Labeler - REMEDYREPACK INC. (829572556)

Revised: 7/2022

Document Id: e3a16c44-85d8-d5d8-e053-2a95a90a1aa2

Set id: 1f9efbcb-4b95-49df-95dc-093908c12e44

Version: 5

Effective Time: 20220712

Search by Drug Name or NDC

NDC 70518-2338-00 Miconazole Nitrate 20 mg/g Details

Miconazole Nitrate 20 mg/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70518-2338-00 (70518233800)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1f9efbcb-4b95-49df-95dc-093908c12e44 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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