Clotrimazole by Central Texas Community Health Centers CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 - 45 gm Tube Label

Austin's Health & Human Services Dept.

Clotrim
VAGINAL
1%45gm
W/APL.

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

Clotrimazole VAG.Crm1% 45 gm W/Apl. NDC: 76413-326-45

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

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

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-326(NDC:0472-0220)
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-326-45	1 in 1 CARTON	08/12/2003
1		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074165	08/12/2003

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-326) , RELABEL(76413-326)