FDA Label for Femiclear 2 Day Gentle
View Indications, Usage & Precautions
Femiclear 2 Day Gentle 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.
Active Ingredients
Active ingredients
Vaginal Ointment
Calendula 6X HPUS ............................................................................................... Healing agent
Melaleuca 6X HPUS........................................................................................... Anti-yeast agent
Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent
Itch Relief
Chamomilla 3X HPUS ............................................................... Anti-itch and inflammatory agent
Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent
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.
Ask A Doctor Before Use If You Have:
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
Do Not Use
Do not use
if you are allergic to any ingredient in this product
When Using This Product
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
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
Warnings (Cont.)
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
foul-smelling discharge
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of The Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.
Directions
Directions
Adults and children 12 years or over:
Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
complete directions.
to protect clothes, use panty liner.
fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the 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 - use other 1/2 of the pink tube
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
outside the vagina (vulva) as needed.
Children under 12 years: ask a doctor
Directions
Adults and children 12 years or over:
Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
complete directions.
to protect clothes, use panty liner.
fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the 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 - use other 1/2 of the pink tube
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
outside the vagina (vulva) as needed.
Children under 12 years: ask a doctor
Other Information
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° C – 25° C) If liquefied, 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 Ingredients
Inactive ingredients
Vaginal Ointment: beeswax, essential oil (natural fragrance), oxygenated olive oil
Itch Relief: beeswax, colloidal oatmeal, essential oil (natural fragrance),
oxygenated olive oil
Questions
Questions?
Call 512.401.3572 or visit femiclear.com. OrganiCare, LLC, Austin, TX 78744, USA
Uses
-treats vaginal infections
-releaves external itching and irritation due to vaginal yeast inrfection
Otc - Purpose
-relieves external itching and irritation due to vaginal yeast inrfection
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