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

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

Advanced Ingredient Data


Raw Label Data

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