Clotrimazole

Clotrimazole
SPL v2
SPL
SPL Set ID 388f7e35-efbe-496b-a8d6-518caa22328d
Route
VAGINAL
Published
Effective Date 2023-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Benzyl Alcohol Cetostearyl Alcohol Cetyl Esters Wax Octyldodecanol Polysorbate 60 Water Sodium Phosphate, Monobasic, Monohydrate Sorbitan Monostearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2021-06-29

Description

Drug Facts


Medication Information

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

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
Principal Display Panel 45 G Tube Carton

NDC 61269-220-63

Clotrimazole

Vaginal Cream, USP 1%

Vaginal Antifungal

(with 1 Reusable Applicator)

Cures most vaginal yeast infections

7-day therapy / 7-day treatment

Educational pamphlet enclosed

Net wt. 1.59 oz (45 g) tube

7 day vaginal cream with 1 reusable applicator

H2 pharma


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

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
Principal Display Panel 45 G Tube Carton (PRINCIPAL DISPLAY PANEL - 45 g Tube Carton)

NDC 61269-220-63

Clotrimazole

Vaginal Cream, USP 1%

Vaginal Antifungal

(with 1 Reusable Applicator)

Cures most vaginal yeast infections

7-day therapy / 7-day treatment

Educational pamphlet enclosed

Net wt. 1.59 oz (45 g) tube

7 day vaginal cream with 1 reusable applicator

H2 pharma


Advanced Ingredient Data


Raw Label Data

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