Clotrimazole

Clotrimazole
SPL v1
SPL
SPL Set ID b1a02eef-35f0-4d68-8ee4-0a7357bde00c
Route
VAGINAL
Published
Effective Date 2016-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Benzyl Alcohol Cetostearyl Alcohol Cetyl Esters Wax Octyldodecanol Polysorbate 60 Water Sorbitan Monostearate

Identifiers & Packaging

Marketing Status
ANDA Active Since 1995-12-04

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 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
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

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

Questions Or Comments?

call toll-free, 1-888-827-6222, for our 24 hour automated response system.

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 Gm Tube Label

CommUnityCare Federally Qualified Health Centers

Clotrim

VAGINAL

1%45gm

W/APL.

Date:

Name:

Dr.

USE AS DIRECTED.

123456

1/1/01

Clotrimazole VAG.Crm1% 45 gm W/ Apl.NDC 76413-305-45

Batch: 123456

Lot: 123456

Exp: 1/1/01

Taro

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


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
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)

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

Questions Or Comments? (Questions or comments?)

call toll-free, 1-888-827-6222, for our 24 hour automated response system.

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 Gm Tube Label (PRINCIPAL DISPLAY PANEL - 45 gm Tube Label)

CommUnityCare Federally Qualified Health Centers

Clotrim

VAGINAL

1%45gm

W/APL.

Date:

Name:

Dr.

USE AS DIRECTED.

123456

1/1/01

Clotrimazole VAG.Crm1% 45 gm W/ Apl.NDC 76413-305-45

Batch: 123456

Lot: 123456

Exp: 1/1/01

Taro

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


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