Clotrimazole by A-S Medication Solutions Clotrimazole

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLOTRIMAZOLE- clotrimazole cream 
A-S Medication Solutions

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Clotrimazole

Drug Facts

Active ingredients	Purpose
Clotrimazole USP 1% (50 mg in each applicatorful)	Vaginal antifungal
Clotrimazole USP 1% (external cream)	Vaginal antifungal

Uses

• treats vaginal yeast infections
• relieves external itching and irritation 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 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

• 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, sorbitan monostearate

Questions or comments?

call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

HOW SUPPLIED

Product: 50090-0614

Clotrimazole

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-0614(NDC: 51672-2003)
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)
sorbitan monostearate (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-0614-0	1 in 1 CARTON	11/28/2014	06/30/2018
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	ANDA072641	12/04/1995	06/30/2018

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0614)

Revised: 1/2020

Document Id: bc9c53c1-9982-4771-b184-eff91fb5cf79

34390-5

Set id: bac80746-5cc3-4910-a0af-d43b8242acc6

Version: 9

Effective Time: 20200117

 

A-S Medication Solutions