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NDC 68788-7682-04 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 Preferred Pharmaceuticals, Inc.. 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: 68788-7682-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clotrimazole Vaginal
Product Information
| NDC | 68788-7682 |
|---|---|
| Product ID | 68788-7682_03e3793d-4be6-40ea-bc69-7fab8e7797c1 |
| 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 | 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 | Preferred Pharmaceuticals, Inc. |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074165 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 68788-7682-04 (68788768204)
| NDC Package Code | 68788-7682-4 |
|---|---|
| Billing NDC | 68788768204 |
| Package | 1 TUBE in 1 CARTON (68788-7682-4) / 45 g in 1 TUBE |
| Marketing Start Date | 2020-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 37b02587-1582-49f2-88b9-5a57f3e3a242 Details
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
Inactive ingredients
Principal Display Panel
Actavis
Relabeled by: Preferred Pharmaceuticals Inc.
NDC 68788-7682-04
Compare to the active ingredient
in Gyne-Lotrimin® Vaginal Cream*
Clotrimazole
Vaginal Cream, USP 1%
Vaginal Antifungal
Cures Most Vaginal Yeast Infections
1 Reusable Applicator (7-Day Therapy)
7-Day Treatment
One 45 g (1.5 OZ) Tube of Vaginal Cream (1%) and
1 Reusable Applicator (7-Day Therapy)
Educational Pamphlet Enclosed
INGREDIENTS AND APPEARANCE
| CLOTRIMAZOLE
clotrimazole cream |
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| Labeler - Preferred Pharmaceuticals, Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals, Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals, Inc. | 791119022 | RELABEL(68788-7682) | |
Revised: 4/2022
Document Id: 03e3793d-4be6-40ea-bc69-7fab8e7797c1
Set id: 37b02587-1582-49f2-88b9-5a57f3e3a242
Version: 3
Effective Time: 20220420