FDA Label for Femiclear Infection Protection
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - ASK DOCTOR
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Femiclear Infection Protection 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.
Otc - Active Ingredient
Melaleuca 6X HPUS ................................................... Anti-yeast agent
Olive Extract (Oleuropein) 5X HPUS..... Anti-microbial and healing agent
Thymol 6X HPUS .................................................. Anti-bacterial agent
Indications & Usage
This product is intended to help prevent bacterial vaginosis (BV) and
yeast infections, and to moisturize.
Warnings
For vaginal use only.
FemiClear may damage condoms and diaphragms and cause
them to fail.
FemiClear does not prevent sexually transmitted infections (STIs).
Practice safer sex by using a latex or polyurethane condom to
reduce the risk of getting STIs.
FemiClear does not eliminate the risk of infections.
Otc - Do Not Use
if you are allergic to any ingredient in this product
Otc - When Using
can be used in combination with other medications, please consult a
healthcare professional
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).
Otc - Stop Use
rash or allergic reaction develops
vaginal symptoms develop you get a rash or hives, abdominal
pain, fever, chills, nausea or vomiting
Otc - Pregnancy Or Breast Feeding
ask a healthcare professional before use.
Otc - Ask Doctor
rash or allergic reaction develops
vaginal symptoms develop you get a rash or hives, abdominal
pain, fever, chills, nausea or vomiting
Dosage & Administration
Directions
Adults and children 12 years or over:
Wash hands before and after use.
Squeeze desired amount into applicator.
Insert applicator into vagina and inject cream.
Clean applicator after use and reuse.
Children under 12 years: ask a doctor
Other Safety Information
do not use if applicator wrapper is torn, open or incompletely sealed
do not use if seal over tube opening has been punctured
Store at 68° – 77° F (20° C – 25° C)
Inactive Ingredient
Water, Oxygenated Olive Oil, essential oil (natural fragrance), Cetearyl
Olivate, Sorbitan Olivate, Xanthan Gum, Cetyl Esters, Phenethyl Alcohol,
Pentylene Glycol, Hyaluronic Acid
Otc - Questions
Call 512.401.3572 or visit femiclear.com.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.
Otc - Purpose
This product is intended to help prevent bacterial vaginosis (BV) and
yeast infections, and to moisturize.
* Please review the disclaimer below.