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Clotrimazole by Rebel Distributors Corp.

Dosage form: cream
Ingredients: CLOTRIMAZOLE 50mg in 1g
Labeler: Rebel Distributors Corp.
NDC Code: 21695-935

Clotrimazole Drug Facts

Active ingredient

Clotrimazole 50mg


Vaginal antifungal/external vulvar antifungal

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Treats vaginal yeast (candida) infections

Relieves external vulvar itching and irritation associated with a yeast infection


For vaginal or external vulvar use only.

Do not use:

° If you have abdominal pain, fever, or a foul smelling vaginal discharge.

Contact your doctor immediately.

° In children less than 12 years of age.

Ask a doctor before use if you have:

° vaginal or vulvar itching and discomfort for the first time. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this cream as directed for 7 days in a row.

° symptoms that return within 2 months or infections that do not clear up easily with proper treatment. You could be pregnant, or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infection from HIV - the virus that causes AIDS). Please read enclosed educational pamphlet.

When using this product do not use tampons.

Stop use and ask a doctor if:

symptoms do not get better in 3 days or infection isn't gone in 7 days. You may have a condition other than a yeast infection.

If pregnant or breast-feeding, ask a health professional before use.


° before using this product, read the enclosed pamphlet

° fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Throw applicator away after use.

° for relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching. The cream should not be used for vulvar itching due to causes other than a yeast infection.

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

° safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.

Questions? 1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday-Friday.

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate.

Package/Label Principal Display Panel

clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-935(NDC:0472-0220)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:21695-935-4545 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Rebel Distributors Corp. (118802834)
Rebel Distributors Corp.118802834RELABEL, REPACK

Revised: 05/2011
Rebel Distributors Corp.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.