MICONAZOLE NITRATE - miconazole nitrate cream 
Central Texas Community Health Centers

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Miconazole nitrate

ACTIVE INGREDIENT

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

PURPOSE

Vaginal antifungal

USES

• treats repeat vaginal yeast infections
• relieves external itching and irritation due to a repeat 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 medication warfarin, because bleeding or bruising may occur.

When using this product
• do not use tampons, douches, spermicides, or other vaginal products
• do not have vaginal intercourse
• condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)

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 right away.

DOSAGE & ADMINISTRATION

• before using this product read the enclosed consumer information leaflet for complete instructions
• adults and children 12 years of age and over:
         • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
         • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated  
             skin outside the vagina. Use daily for up to 7 days as needed
• children under 12 years of age: ask a doctor

OTHER INFORMATION

• do not use if seal over tube opening has been punctured or cannot be seen
• store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.

INACTIVE INGREDIENT

benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

PRINCIPAL DISPLAY PANEL - 45 g Tube Label

CommUnityCare Federally Qualified Health Centers

MICONAZOLE
2% VAGINAL
CREAM

Date:

Name:
Dr.

USE AS DIRECTED

123456

1/1/01

MICONAZOLE 2% VAG.CRM 45gNDC 76413-318-45

Batch: 123456
Lot: 123456
Exp: 1/1/01
G&W LABS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Principal Display Panel - 45 g Tube Label
MICONAZOLE NITRATE  
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-318(NDC:0713-0252)
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzoic Acid (UNII: 8SKN0B0MIM)  
Butylated Hydroxyanisole (UNII: REK4960K2U)  
Mineral Oil (UNII: T5L8T28FGP)  
Peg-5 Oleate (UNII: 0240V77G50)  
Pegoxol 7 Stearate (UNII: 3EW5AXE5X5)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76413-318-451 in 1 CARTON02/22/1996
145 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07436602/22/1996
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK(76413-318) , RELABEL(76413-318)

Revised: 4/2016
Document Id: 6f218797-be08-4b07-8c82-21e2b57f0eb1
Set id: 0878a5d4-d6c7-4e66-8956-9bd1acd9dfd4
Version: 1
Effective Time: 20160421
 
Central Texas Community Health Centers