FEMICLEAR YEAST INFECTION TREATMENT- olive extract, calendula, melaleuca kit

FemiClear by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Calendula 3X HPUS

Melaleuca 3X HPUS

Olive Extract 2X HPUS

PURPOSE

Purposes

Healing Agent

Anti-Yeast Agent

Antimicrobial and Healing Agent

INDICATIONS & USAGE

Uses

See your doctor if this is the first time you have vaginal itching and discomfort to find out if you have a vaginal yeast infection.

• Treats repeat vaginal yeast infections
• To relieve external itching and irritation due to a repeat vaginal yeast infection

WARNINGS

Warnings

For vaginal use only.

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

ASK DOCTOR

Ask a doctor before use if you

• Have 1 or more of the following: abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge
• Get vaginal yeast infections often (such as once a month or three in 6 months)
• May have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
• Are under 12 years of age.

WHEN USING

When using this product

• Do not have vaginal intercourse
• Do not use tampons, douiches, spermicides, or other vaginal products

STOP USE

Stop use and ask a doctor if

• Symptoms do not improve in 3 days
• Symptoms remain after 7 days
• You get abdominal pain, fever, chills, vomiting, foul-smelling discharge, or hives

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• Before use at bedtime, read enclosed instructions for complete directions.
• Adults and children 12 years and older:
• Refrigerate Vaginal Ointment for 20 minutes immediately before use.
• To protect clothes, use panty liner.
• Fill applicator with FemiClear Vaginal Ointment as shown.
• Lie down in bed. Insert applicator into vagina and inject Femiclear. Remain lying down to avoid leakage. Repeat on second night. Discard applicator after each use.
• External Itch Ointment: Squeeze a small amount of ointment onto your fingertip. Apply the ointment onto the itchy, irritated skin outside the vagina. Use as needed.
• Children under 12 years old: ask a doctor

STORAGE AND HANDLING

Other information

• Store at 68-77°F (20-25°C)
• if liquified, refrigerate 20 minutes to thicken

INACTIVE INGREDIENT

Inactive ingredients

oxygenated olive oil, pure essential oil (lavender)

QUESTIONS

Questions?

Call 512-401-3572 or visit FemiClear.com

SPL UNCLASSIFIED SECTION

Distributed by

OrganiCare®

Austin, TX 78744

Made in Italy

PRINCIPAL DISPLAY PANEL

No Artificial Antifungal Drugs or Chemicals

FemiClear™

Yeast Infection Treatment

All-Natural and Organic

Homeopathic Medicine

Shortest Effective Remedy

2 Day Dose

1 tubes, Net Wt. 0.5 oz (14.2 g) each, Total Wt. 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

FEMICLEAR   YEAST INFECTION TREATMENT
olive extract, calendula, melaleuca kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71042-007

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-007-28	1 in 1 CARTON; Type 0: Not a Combination Product	12/20/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	14 g
Part 2	1 TUBE	14 g

Part 1 of 2

FEMICLEAR VAGINAL 
olive extract, calendula, melaleuca ointment

Product Information
Item Code (Source)	NDC: 71042-008
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	3 [hp_X]  in 14 g
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J)	OLEA EUROPAEA FRUIT VOLATILE OIL	2 [hp_X]  in 14 g
MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU)	MELALEUCA CAJUPUTI LEAF OIL	3 [hp_X]  in 14 g

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-008-14	14 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		12/20/2017

Part 2 of 2

FEMICLEAR EXTERNAL ANTI-ITCH 
olive extract, calendula, melaleuca ointment

Product Information
Item Code (Source)	NDC: 71042-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J)	OLEA EUROPAEA FRUIT VOLATILE OIL	2 [hp_X]  in 14 g
MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU)	MELALEUCA CAJUPUTI LEAF OIL	3 [hp_X]  in 14 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	3 [hp_X]  in 14 g

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-009-14	14 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		12/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/20/2017

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