Clotrimazole CLOTRIMAZOLE STRATEGIC SOURCING SERVICES LLC FDA Approved Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
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Substance Clotrimazole
Route
VAGINAL
Applications
ANDA072641
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Purpose Clotrimazole USP 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP 1% (external cream) Vaginal antifungal
Inactive Ingredients
Inactive ingredients 2-octyldodecanol benzyl alcohol cetostearyl alcohol cetyl esters wax polysorbate 60 purified water sorbitan monostearate
Strengths
1 % 50 mg
Treats Conditions
Uses Treats Vaginal Yeast Infections Relieves External Itching And Irritation Due To A Vaginal Yeast Infection

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
G07GZ97H65
Packaging

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton Foster & Thrive™ 7 DAY TREATMENT 7 Day Vaginal Cream Clotrimazole Vaginal Cream USP 1% VAGINAL ANTIFUNGAL Cures Most Vaginal Yeast Infections Educational Brochure Enclosed One 45 g (1.5 oz) Tube of Clotrimazole Vaginal Cream USP 1% & 1 Reusable Applicator Principal Display Panel - 45 g Tube Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton Foster & Thrive™ 7 DAY TREATMENT 7 Day Vaginal Cream Clotrimazole Vaginal Cream USP 1% VAGINAL ANTIFUNGAL Cures Most Vaginal Yeast Infections Educational Brochure Enclosed One 45 g (1.5 oz) Tube of Clotrimazole Vaginal Cream USP 1% & 1 Reusable Applicator Principal Display Panel - 45 g Tube Carton

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

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

Do Not Use

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

When Using

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 & Ask a Doctor

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Storage & Handling

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

Questions

Questions or comments? call 833-358-6431


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