Label: CLOTRIMAZOLE cream
- NDC Code(s): 68788-8330-4
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 61269-220
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 5, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Ask a doctor before use if you have
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- vaginal itching and discomfort for the first time
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- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
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- 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.
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- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
When using this product
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- 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).
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- do not have vaginal intercourse
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- mild increase in vaginal burning, itching or irritation may occur
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- if you do not get complete relief, ask a doctor before using another product
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Directions
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- before using this product, read the enclosed educational brochure for complete directions and information
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- adults and children 12 years of age and over:
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- vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
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- 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.
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- children under 12 years of age: ask a doctor
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Other information
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- to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
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- do not use if foil seal on tube opening is broken or missing
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- do not purchase if carton is open
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- store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
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- before using any medication, read all label directions. Keep carton, it contains important information.
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
www.h2-pharma.comRelabeled By: Preferred Pharmaceuticals Inc.
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PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
NDC 68788-8330-4
Clotrimazole
Vaginal Cream, USP 1%Vaginal Antifungal
(with 1 Reusable Applicator)Cures most vaginal yeast infections
7-day therapy / 7-day treatment
Educational pamphlet enclosedNet wt. 1.59 oz (45 g) tube
7 day vaginal cream with 1 reusable applicator
H2 pharma
Relabeled By: Preferred Pharmaceuticals Inc.
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8330(NDC:61269-220) Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ESTERS WAX (UNII: D072FFP9GU) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-8330-4 1 in 1 CARTON 01/20/2023 1 45 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074165 01/20/2023 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-8330)