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NDC 63868-0259-15 Clotrimazole 10 mg/g Details
Clotrimazole 10 mg/g
Clotrimazole is a VAGINAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is CLOTRIMAZOLE.
MedlinePlus Drug Summary
Vaginal clotrimazole is used to treat vaginal yeast infections in adults and children 12 years of age and older.. Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Related Packages: 63868-0259-15Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Vaginal
Product Information
| NDC | 63868-0259 |
|---|---|
| Product ID | 63868-259_77ae462c-38b6-4b2f-b0cf-3b6a168d0c4a |
| Associated GPIs | 55104020003705 |
| GCN Sequence Number | 006999 |
| GCN Sequence Number Description | clotrimazole CREAM/APPL 1 % VAGINAL |
| HIC3 | Q4F |
| HIC3 Description | VAGINAL ANTIFUNGALS |
| GCN | 28360 |
| HICL Sequence Number | 004137 |
| HICL Sequence Number Description | CLOTRIMAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Clotrimazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Clotrimazole |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | VAGINAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | CLOTRIMAZOLE |
| Labeler Name | QUALITY CHOICE (Chain Drug Marketing Association) |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074165 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0259-15 (63868025915)
| NDC Package Code | 63868-259-15 |
|---|---|
| Billing NDC | 63868025915 |
| Package | 1 TUBE in 1 CARTON (63868-259-15) / 45 g in 1 TUBE |
| Marketing Start Date | 2014-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.08957 |
| Pricing Unit | GM |
| Effective Date | 2022-11-23 |
| NDC Description | QC CLOTRIMAZOLE 1% VAG CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
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 cd3b71ad-eda6-43ed-8b7c-e75354f8610c Details
Active ingredients
Uses
Warnings
For vaginal use only
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
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
Directions
- before using this product, read the enclosed educational brochure for complete directions and information
- adults and children 12 years of age and over:
- vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
- external cream: 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. Use 2 times daily for up to 7 days as needed.
- children under 12 years of age: ask a doctor
Other information
- to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
- do not use if foil seal on tube opening is broken or missing
- do not purchase if carton is open
- store at room temperature 20º to 25ºC (68º to 77ºF)
- before using any medication, read all label directions. Keep carton, it contain important information.
Inactive ingredients
Principal display panel
Educational Pamphlet Enclosed
7-Day Treatment
Clotrimazole
Vaginal Cream USP, 1%
Vaginal Antifungal
Clotrimazole Vaginal Cream Can Kill The Yeast That May Cause Vaginal Infection
Cures Most Vaginal Yeast Infections
One 45g (1.59 OZ) Tube of Vaginal Cream (1%) and 1 Reusable Applicator (7-Day Therapy
Distributed by CDMA, Inc.
Novi, MI 48375
INGREDIENTS AND APPEARANCE
| CLOTRIMAZOLE
clotrimazole cream |
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| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |
Revised: 9/2022
Document Id: 77ae462c-38b6-4b2f-b0cf-3b6a168d0c4a
Set id: cd3b71ad-eda6-43ed-8b7c-e75354f8610c
Version: 10
Effective Time: 20220930