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Clotrimazole by Central Texas Community Health Centers

Dosage form: cream
Ingredients: CLOTRIMAZOLE 1g in 100g
Labeler: Central Texas Community Health Centers
NDC Code: 76413-327

Clotrimazole Vaginal Cream

Drug Facts

Active ingredients

Clotrimazole 1% (50 mg in each applicatorful)

Clotrimazole 1% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

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

Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

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

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.

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

Questions?

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

PRINCIPAL DISPLAY PANEL - 28 g Tube Label

Austin's Health & Human Services Dept.

Clotrimazole
1%
TOPICAL
Cream

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

Clotrimazole 1% TOPICAL Cream 30g NDC 76413-327-30

Batch: 123456
Lot: 123456
Exp: 1/1/01
PERRIGO

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

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-327(NDC:45802-434)
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETOSTEARYL ALCOHOL 
CETYL ESTERS WAX 
OCTYLDODECANOL 
POLYSORBATE 60 
WATER 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage Description
1NDC:76413-327-301 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416508/12/2003
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-327), RELABEL(76413-327)

 
Central Texas Community Health Centers

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Medically reviewed on Nov 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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