FEMICLEAR INFECTION PROTECTION- vaginal cream cream

FemiClear Infection Protection by

Drug Labeling and Warnings

FemiClear Infection Protection by is a Homeopathic medication manufactured, distributed, or labeled by OrganiCare Nature's Science, LLC, OrganiCare Nature's Science. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DO NOT USE

if you are allergic to any ingredient in this product

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).

STOP USE

 rash or allergic reaction develops
 vaginal symptoms develop  you get a rash or hives, abdominal
pain, fever, chills, nausea or vomiting

PREGNANCY OR BREAST FEEDING

ask a healthcare professional before use.

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

QUESTIONS

Call 512.401.3572 or visit femiclear.com.

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.

PURPOSE

This product is intended to help prevent bacterial vaginosis (BV) and
yeast infections, and to moisturize.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEMICLEAR INFECTION PROTECTION 
vaginal cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71042-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELALEUCA CAJUPUTI WHOLE (UNII: K62C66D9LN) (MELALEUCA CAJUPUTI WHOLE - UNII:K62C66D9LN)	MELALEUCA CAJUPUTI WHOLE	0.01 g  in 1 g
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PENTYLENE GLYCOL (UNII: 50C1307PZG)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONIC ACID (NON-ANIMAL STABILIZED) (UNII: B7SG5YV2SI)
CETYL ESTERS WAX (UNII: D072FFP9GU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-028-14	1 in 1 CARTON	08/07/2023
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/07/2023

Labeler - OrganiCare Nature's Science, LLC (044204745)

Establishment
Name	Address	ID/FEI	Business Operations
OrganiCare Nature's Science		044204745	manufacture(71042-028)