The following Structured Product Label (SPL) was submitted to the FDA by Organicare Nature's Science, Llc for the product Femiclear Infection Protection (NDC 71042-028). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Melaleuca 6X HPUS ................................................... Anti-yeast agent
Olive Extract (Oleuropein) 5X HPUS..... Anti-microbial and healing agent
Thymol 6X HPUS .................................................. Anti-bacterial agent
This product is intended to help prevent bacterial vaginosis (BV) and
yeast infections, and to moisturize.
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.
if you are allergic to any ingredient in this product
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).
rash or allergic reaction develops
vaginal symptoms develop you get a rash or hives, abdominal
pain, fever, chills, nausea or vomiting
ask a healthcare professional before use.
rash or allergic reaction develops
vaginal symptoms develop you get a rash or hives, abdominal
pain, fever, chills, nausea or vomiting
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
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)
Water, Oxygenated Olive Oil, essential oil (natural fragrance), Cetearyl
Olivate, Sorbitan Olivate, Xanthan Gum, Cetyl Esters, Phenethyl Alcohol,
Pentylene Glycol, Hyaluronic Acid
Call 512.401.3572 or visit femiclear.com.
Keep out of the reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.
This product is intended to help prevent bacterial vaginosis (BV) and
yeast infections, and to moisturize.
* Please review the disclaimer below.
