Clotrimazole
FDA Label NDC 76413-327

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Clotrimazole (NDC 76413-327). 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 active ingredients, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 28 G Tube Label

Active Ingredients

Clotrimazole 1% (50 mg in each applicatorful)

Clotrimazole 1% (external cream)

Purpose

Vaginal antifungal

Uses

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

Warnings

For vaginal use only

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

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

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