clotrimazole vaginal cream, usp

clotrimazole vaginal cream, usp
SPL v9
SPL
SPL Set ID 6ea3291c-5b21-4e2b-b114-b491fa33298c
Route
vaginal
Published
Effective Date 2021-02-23
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

Marketing Status
anda active Since 2003-07-01

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)


Medication Information

Warnings

For vaginal use only

Uses
  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection
Purpose

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



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

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)

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Do Not Use

if you have never had a vaginal yeast infection diagnosed by a doctor

Clotrimazole
Active Ingredients

Clotrimazole, USP 1% (50 mg in each applicatorful)

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

Warnings

For vaginal use only

Uses
  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection
Purpose

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



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.
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

How Supplied (HOW SUPPLIED)

Product: 50090-1522

NDC: 50090-1522-0 45 g in a TUBE / 7 in a CARTON

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Do Not Use (Do not use)

if you have never had a vaginal yeast infection diagnosed by a doctor

Clotrimazole (clotrimazole)
Active Ingredients (Active ingredients)

Clotrimazole, USP 1% (50 mg in each applicatorful)

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

Advanced Ingredient Data


Raw Label Data

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