Label: SUNMARK CLOTRIMAZOLE 3- clotrimazole cream
- NDC Code(s): 49348-379-54
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients Purpose Clotrimazole USP 2% (100 mg in each applicatorful) Vaginal Antifungal Clotrimazole USP 2% (external cream) Vaginal Antifungal
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
For vaginal use only
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
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 3 days in a row. Throw applicator away after 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 monostearateClose
- Questions or comments?
Call toll-free, 1-888-827-6222, for our 24 hour automated response system.Close
- SPL UNCLASSIFIED SECTION
Distributed by McKessonClose
One Post Street
San Francisco, CA 94104
- PRINCIPAL DISPLAY PANEL - 21 g Tube Carton
Clotrimazole Vaginal Cream USP (2%)
Cures Most Vaginal Yeast Infections
3 DAY TREATMENT
One 21 g (0.74 oz) Tube Of Clotrimazole Vaginal Cream USP (2%)
& 3 Disposable Applicators
- INGREDIENTS AND APPEARANCE
SUNMARK CLOTRIMAZOLE 3
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-379 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 2 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:49348-379-54 1 in 1 CARTON 1 21 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021143 04/12/2000 Labeler - McKesson (177667227) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-379)