Label: CLOTRIMAZOLE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68788-0169-4 - Packager: Preferred Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0472-0220
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 16, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
For vaginal use only
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. - •
- children under 12 years of age: ask a doctor
- Other Information
- Inactive ingredients
- Questions?
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Principal Display Panel
45g tube - 68788-0169-4
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 TreatmentONE 45 g (1.5 OZ) Tube of Vaginal Cream (1%) and
1 Reusable Applicator (7-Day Therapy)Educational Pamphlet Enclosed
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0169(NDC:0472-0220) Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-0169-4 1 in 1 CARTON 08/06/2013 1 45 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074165 08/06/2013 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 RELABEL(68788-0169)
