Clotrimazole
6b908538-d9ff-41d0-909c-01e1d1b21a39
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
How Supplied
Product: 50090-7376 NDC: 50090-7376-0 45 g in a TUBE, WITH APPLICATOR / 1 in a CARTON
Medication Information
How Supplied
Product: 50090-7376
NDC: 50090-7376-0 45 g in a TUBE, WITH APPLICATOR / 1 in a CARTON
Description
Drug Facts
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50570-1
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
| Active ingredients | Purpose |
|---|---|
| Clotrimazole USP, 1% (50 mg in each applicatorful) | Vaginal antifungal |
| Clotrimazole USP, 1% (external cream) | Vaginal antifungal |
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
Questions?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Clotrimazole
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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
- before using any medication, read all label directions. Keep carton, it contains important information.
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
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
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50570-1 (50570-1)
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
| Active ingredients | Purpose |
|---|---|
| Clotrimazole USP, 1% (50 mg in each applicatorful) | Vaginal antifungal |
| Clotrimazole USP, 1% (external cream) | Vaginal antifungal |
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
Questions?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Clotrimazole
How Supplied (HOW SUPPLIED)
Product: 50090-7376
NDC: 50090-7376-0 45 g in a TUBE, WITH APPLICATOR / 1 in a CARTON
Other Information (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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
- before using any medication, read all label directions. Keep carton, it contains important information.
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
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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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:57.904824 · Updated: 2026-03-14T23:04:20.034852