FEMICLEAR BACTERIAL VAGINOSIS SYMPTOMS- thymol with olive extract ointment

FemiClear Bacterial Vaginosis Symptoms by

Drug Labeling and Warnings

FemiClear Bacterial Vaginosis Symptoms by is a Homeopathic medication manufactured, distributed, or labeled by Organicare Nature's Science, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Thymol 6X HPUS

Olive Extract (Oleuropein) 3X HPUS

Purpose

Anti-bacterial agent

Anti-microbial and Healing agent

Uses

This product is intended to relieve symptoms associated with known bacterial vaginosis infecions, including fishy odor, excess discharge, irritation and burning while urinating.

Warnings

For vaginal use only.

Do not use if you have never had a bacterial vaginosis infection diagnosed by a doctor.

Ointment may damage condoms and diaphragms and cause them to fail.

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.
• bacterial vaginosis 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

if you are allergic to any ingredient in 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 relief, consult a doctor

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 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 Poison Control Center right away

Directions

Adults and children 12 years of age and older:

• Use at bed time, read enclosed instructions for complete directions.
• to protect clothes, use a panty liner.
• fill applicator with Vaginal Ointment - use 1/2 of the tube
• lie down in bed. Insert applicator into vagina and inject ointment. Remain lying down to avoid leakage.
• discard applicator after use. DO NOT reuse.
• repeat on second night - use other 1/2 of the tube

Children under 12 years: ask a doctor

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
• Store at 68°-77°F (20°C - 25°C) If liquified, refrigerate 10 minutes to thicken.
• this is 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.

Inactve ingredients

beeswax, essential oil (natural fragrance), oxygenated olive oil

Questions?

Call 512.401.3572 or visit femiclear.com

Made and Distributed by OrganiCare, LLC

Austin, TX 78744, USA

SPL UNCLASSIFIED SECTION

Claims based on clinical and/or in vitro laboratory

(non-human/non-animal) studies, and traditional homeopathic practice (not accepted clinical medical evidence; not FDA evaluated).

See FemiClear.com

Made and Distributed by

Organicare

Austin, TX 78744, USA

PRINCIPAL DISPLAY PANEL

FemiClear®

Bacterial Vaginosis Symptoms

90% Reported a Reduction in

• Fishy Odor
• Itching
• Excess Discharge

MADE WITH ORGANIC INGREDIENTS

KILLS 99.9% OF BACTERIA CAUSING BV

GARDNERELLA VAGINALIS

HOMEOPATHIC MEDICINE

INGREDIENTS AND APPEARANCE

FEMICLEAR BACTERIAL VAGINOSIS SYMPTOMS 
thymol with olive extract ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71042-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	6 [hp_X]  in 100 g
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEUROPEIN - UNII:2O4553545L)	OLEUROPEIN	3 [hp_X]  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-025-14	1 in 1 CARTON	06/01/2022
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		06/01/2022

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

Registrant - Organicare Nature's Science, LLC (044204745)

Establishment
Name	Address	ID/FEI	Business Operations
Organicare Nature's Science, LLC		044204745	manufacture(71042-025)