OTC Medication Information: Clotrimazole

CLOTRIMAZOLE- clotrimazole cream
QUALITY CHOICE (Chain Drug Marketing Association)

Drug Facts

Active ingredients

Clotrimazole, USP 1% (50 mg in each applicatorful)

Clotrimazole USP, 1% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Uses

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a 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

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

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 a 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 (1-800-222-1222) right away.

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

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

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

www.qualitychoice.com

Package label

Clotrimazole, USP 1% (50 mg in each applicatorful), Clotrimazole, USP 1% (external cream)
(click image for full-size original)

QUALITY CHOICE Vaginal Antifungal Cream

CLOTRIMAZOLE
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-259
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETOSTEARYL ALCOHOL
CETYL ESTERS WAX
OCTYLDODECANOL
POLYSORBATE 60
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SORBITAN MONOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-259-15 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (63868-259-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074165 10/15/2014
Labeler — QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 09/2022 QUALITY CHOICE (Chain Drug Marketing Association)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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