FDA Label for Femiclear Yeast Infection Treatment
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Femiclear Yeast Infection Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Organicare Nature's Science, Llc. 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
Made and Distributed by
OrganiCare®
Austin, TX 78744, USA
Claims based on clinical and/or in vitro laboratory (non-human/non-animal) studies, and traditional homeopathic practice (not accepted clinical medical evidence; not FDA evaluated). See FemiClear.com.
Otc - Active Ingredient
Active ingredients
Vaginal Ointment
Calendula 3X HPUS
Melaleuca 3X HPUS
Olive Extract (Oleuropein) 3X HPUS
Itch Relief
Chamomilla 3X HPUS
Olive Extract (Oleuropein) 3X HPUS
Otc - Purpose
Purposes
Healing agent
Anti-yeast agent
Antimicrobial and healing agent
Anti-itch and inflammatory agent
Anti-microbial and healing agent
Indications & Usage
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Warnings
Warnings
For vaginal use only.
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
FemiClear may damage condoms and diaphragms and cause them to fail.
Otc - Ask 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 three 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
Otc - Do Not Use
Do not use
- if you are allergic to any ingredient in this product
Otc - When Using
When using this product
- do not use tampons, douiches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted infections (STIs)
- 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
Otc - Stop Use
Stop use and ask a doctor if
- symptoms do not improve in 3 days
- symptoms remain after 7 days
- you get abdominal pain, fever, chills, vomiting, foul-smelling discharge, or hives
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.
Dosage & Administration
Directions
- Adults and children 12 years or over:
- to protect clothes, use panty liner
- fill applicator with FemiClear Vaginal Ointment (pink tube).
- lie down in bed. Insert applicator into vagina and inject Femiclear. Remain lying down to avoid leakage.
- discard applicator after use. DO NOT reuse.
- repeat on second night.
- Children under 12 years: ask a doctor
Vaginal Ointment: use at bedtime, read enclosed instructions for complete directions.
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin outside the vagina (vulva) as needed.
Storage And Handling
Other information
- do not use if applicator wrapper is torn, open, or incompletely sealed
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- Store at 68-77°F (20-25°C). If liquified, refrigerate 10 minutes to thicken.
- this a 2-dose treatment. Most women do not get complete relief of their symptoms in just 2 days. Most women get some improvement in 2 days and complete relief by 7 days.
Inactive Ingredient
Inactive ingredients
Vaginal Ointment: beeswax, essential oil (natural fragrance), oxygenated olive oil
Itch Relief: beeswax, colloidal oatmeal, essential oil (natural fragrance), oxygenated olive oil
Otc - Questions
Questions?
Call 512-401-3572 or visit FemiClear.com
Organicare, LLC, Austin, TX 78744, USA
Package Label.Principal Display Panel
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