FDA Label for Good Neighbor Pharmacy Clotrimazole 3

View Indications, Usage & Precautions

Good Neighbor Pharmacy Clotrimazole 3 Product Label

The following document was submitted to the FDA by the labeler of this product Amerisourcebergen. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087


Otc - Purpose



Active ingredientsPurpose
Clotrimazole USP 2% (100 mg in each applicatorful)Vaginal antifungal
Clotrimazole USP 2% (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


Otc - Do Not Use



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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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 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 monostearate


Questions Or Comments?



call 1-866-923-4914


Principal Display Panel - 21 G Tube Carton



Compare to Gyne-Lotrimin 3® active ingredient *

GOOD
NEIGHBOR
PHARMACY®

NDC 24385-110-09

3 Day Treatment

Clotrimazole 3
Clotrimazole Vaginal Cream USP (2%)
Vaginal Antifungal

Educational Brochure Enclosed

Vaginal Cream Cures Most Vaginal Yeast Infections

One 21 g (0.74 oz) Tube Of Clotrimazole Vaginal Cream USP (2%)
and 3 Disposable Applicators


* Please review the disclaimer below.