FEMICLEAR VULVA CREAM cream

FemiClear Vulva Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARNINGS

For external 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 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

 do not use in or near the eyes

Stop use and ask a doctor if  rash or allergic reaction
develops  vaginal symptoms develop  you get a rash or
hives, abdominal pain, fever, chills, nausea or vomiting

If pregnant or breast-feeding, ask a healthcare professional
before use.

Keep out of the reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

ACTIVE INGREDIENT

Melaleuca 6X HPUS................................................ Anti-yeast agent
Olive Extract (Oleuropein) 5X HPUS ...Anti-microbial and healing agent
Thymol 6X HPUS................................................Anti-bacterial agent

INACTIVE INGREDIENT

Water, Oxygenated Olive Oil, essential oil (natural fragrance),
Cetearyl Olivate, Sorbitan Olivate, Xanthan Gum, Cetyl Esters,
Castor Seed Oil, Hydrogenated Castor Oil, Carnauba Wax, Phenethyl
Alcohol, Pentylene Glycol, Hyaluronic Acid

QUESTIONS

Questions?
Call 512.401.3572 or visit femiclear.com

DOSAGE & ADMINISTRATION

Squeeze onto fingertip and apply generously all over vulva including urethra. Ues as often as needed.

INDICATIONS & USAGE

Use as often as needed.

PURPOSE

This product is intended to help prevent urinary tract infections (UTIs) and moisturize.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEMICLEAR VULVA CREAM 
femiclear vulva cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71042-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.0001 kg  in 100 kg
MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU)	MELALEUCA CAJUPUTI LEAF OIL	0.0001 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)	1 kg  in 100 kg
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.5 kg  in 100 kg
XANTHAN GUM (UNII: TTV12P4NEE)	0.2 kg  in 100 kg
PENTYLENE GLYCOL (UNII: 50C1307PZG)	2 kg  in 100 kg
CETYL ESTERS WAX (UNII: D072FFP9GU)	6 kg  in 100 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-027-14	1 in 1 CARTON	07/17/2023
1		0.142 kg 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		07/17/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
OrganiCare Nature's Science, LLC		044204745	manufacture(71042-027)