The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
For vaginal use only.
Distributed by: H2-Pharma, LLCMontgomery, AL 36117www.h2-pharma.com
Otc - Purpose
Active ingredientsPurposeClotrimazole USP, 1% (50 mg in each applicatorful)Vaginal antifungalClotrimazole USP, 1% (external cream)Vaginal antifungal
- Treats vaginal yeast infectionsrelieves external itching and irritation due to a vaginal yeast infection
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 timelower 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 intercoursemild increase in vaginal burning, itching or irritation may occurif 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 dayssymptoms last more than 7 daysyou 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 (1-800-222-1222) right away.
- Before using this product, read the enclosed educational brochure for complete directions and informationadults 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
- To open tube: unscrew cap, lift tab, and pull to remove foil seal prior to usedo not use if foil seal on tube opening is broken or missingdo not purchase if carton is openstore at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)before using any medication, read all label directions. Keep carton, it contains important information.
Benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
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