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Clotrimazole by REMEDYREPACK INC.

Medically reviewed on February 17, 2017

Dosage form: cream
Ingredients: CLOTRIMAZOLE 1g in 100g
Labeler: REMEDYREPACK INC.
NDC Code: 61786-091

Clotrimazole

Drug Facts

Active ingredientsPurpose
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, and sorbitan monostearate

Questions or comments?

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

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

DRUG: Clotrimazole

GENERIC: Clotrimazole

DOSAGE: CREAM

ADMINSTRATION: VAGINAL

NDC: 61786-091-46

PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • Clotrimazole 1g in 100g

INACTIVE INGREDIENT(S):

  • benzyl alcohol
  • polysorbate 60
  • water
  • octyldodecanol
  • cetostearyl alcohol
  • cetyl esters wax
  • sorbitan monostearate

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-091(NDC:51672-2003)
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 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage Description
1NDC:61786-091-4645 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07264111/11/2014
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Further information

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

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