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



Drug Facts

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


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


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.


  • 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


Product: 50090-0614


Label Image
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-0614(NDC: 51672-2003)
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
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)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-0614-01 in 1 CARTON11/28/201406/30/2018
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - A-S Medication Solutions (830016429)
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0614)

Revised: 1/2020
A-S Medication Solutions