Clotrimazole Vaginal Cream, Usp
6ea3291c-5b21-4e2b-b114-b491fa33298c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Clotrimazole, USP 1% (50 mg in each applicatorful)
Purpose
Vaginal antifungal
How Supplied
Product: 50090-1522 NDC: 50090-1522-0 45 g in a TUBE / 7 in a CARTON
Medication Information
Purpose
Vaginal antifungal
How Supplied
Product: 50090-1522
NDC: 50090-1522-0 45 g in a TUBE / 7 in a CARTON
Description
Clotrimazole, USP 1% (50 mg in each applicatorful)
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Warnings
For vaginal use only
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
Do Not Use
if you have never had a vaginal yeast infection diagnosed by a doctor
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
Clotrimazole
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.
Active Ingredients
Clotrimazole, USP 1% (50 mg in each applicatorful)
Inactive Ingredients
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
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.
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
Structured Label Content
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Purpose
Vaginal antifungal
Warnings
For vaginal use only
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
Do Not Use (Do not use)
if you have never had a vaginal yeast infection diagnosed by a doctor
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
How Supplied (HOW SUPPLIED)
Product: 50090-1522
NDC: 50090-1522-0 45 g in a TUBE / 7 in a CARTON
Clotrimazole (clotrimazole)
Other Information (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.
Active Ingredients (Active ingredients)
Clotrimazole, USP 1% (50 mg in each applicatorful)
Inactive Ingredients (Inactive ingredients)
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
When Using This Product (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 (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, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Ask A Doctor Before Use If You Have (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
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:59:25.646948 · Updated: 2026-03-14T22:59:22.971184