Clotrimazole Vaginal Cream Usp 1%
bac80746-5cc3-4910-a0af-d43b8242acc6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
How Supplied
Product: 50090-0614 NDC: 50090-0614-0 45 g in a TUBE / 1 in a CARTON
Medication Information
How Supplied
Product: 50090-0614
NDC: 50090-0614-0 45 g in a TUBE / 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 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 |
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
Clotrimazole
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
2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, sorbitan monostearate
Questions Or Comments?
call 1-866-923-4914
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 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 |
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
Clotrimazole
How Supplied (HOW SUPPLIED)
Product: 50090-0614
NDC: 50090-0614-0 45 g in a TUBE / 1 in a CARTON
Other Information (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 (Inactive ingredients)
2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, sorbitan monostearate
Questions Or Comments? (Questions or comments?)
call 1-866-923-4914
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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Source: dailymed · Ingested: 2026-02-15T12:08:27.285948 · Updated: 2026-03-14T23:12:40.778283