Clotrimazole Cream
FDA Label NDC 51672-2003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Clotrimazole (NDC 51672-2003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

Otc - Purpose

Active ingredientsPurpose
Clotrimazole USP 1% (50 mg in each applicatorful)Vaginal Antifungal
Clotrimazole USP 1% (external cream)Vaginal Antifungal

Uses

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

Warnings

For vaginal use only

Otc - Do Not Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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: unscrew cap, use pointed end on cap to puncture seal
  • do not use if carton is opened
  • safety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product.
  • store between 20° to 25°C (68° to 77°F)
  • see flap of carton or crimp of tube for lot number and expiration date

Inactive Ingredients

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

Questions Or Comments?

call toll-free, 1-888-827-6222, for our 24 hour automated response system.

Principal Display Panel - 45 G Tube Carton

NDC 51672-2003-6

Cures Most Vaginal Yeast Infections

7 Day Treatment

7 Day Vaginal Cream

Clotrimazole Vaginal Cream USP (1%)
Vaginal Antifungal

One 45 g (1.5 oz) Tube Of Clotrimazole Vaginal Cream USP (1%)
& 1 Reusable Applicator

Educational Brochure Enclosed

Principal Display Panel (45 g Tube Carton)

Principal Display Panel (45 g Tube Carton)

* Please review the disclaimer below.