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Clotrimazole by Chain Drug Marketing Association Inc.

Dosage form: cream
Ingredients: CLOTRIMAZOLE 10mg in 1g
Labeler: Chain Drug Marketing Association Inc.
NDC Code: 63868-259

Clotrimazole Vaginal Cream, USP

Drug Facts

Active ingredients

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

Active ingredients

Clotrimazole, USP 1% (external cream)


Vaginal antifungal


Vaginal antifungal

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


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.

  • 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
  • store at room temperature between 2° and 30°C (36° to 86°F)
  • see end flaps of carton and tube for lot number and expiration date
  • Tamper-evident: Safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.

Inactive ingredients

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


1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

Quality Choice®
NDC 63868-259-15 

*Compare to the active ingredient
in Gyne-Lotrimin® Vaginal Cream

Educational Pamphlet Enclosed

7-Day Treatment

Vaginal Cream, USP 1%

Vaginal Antifungal
Cures Most Vaginal Yeast Infections

One 45g (1.5 OZ) Tube of Vaginal Cream (1%) and
1 Reusable Applicator (7-Day Therapy)

clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-259
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:63868-259-151 TUBE in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2017
Chain Drug Marketing Association Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.