FEMICLEAR YEAST INFECTION TREATMENT- calendula, melaleuca, oleuropein, chamomilla 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]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients

Vaginal Ointment

Calendula 3X HPUS

Melaleuca 3X HPUS

Olive Extract (Oleuropein) 3X HPUS

Itch Relief

Chamomilla 3X HPUS

Olive Extract (Oleuropein) 3X HPUS

PURPOSE

Purposes

Healing agent

Anti-yeast agent

Antimicrobial and healing agent

Anti-itch and inflammatory agent

Anti-microbial and healing agent

INDICATIONS & USAGE

Uses

• treats vaginal yeast infections
• relieves external itching and irritation due to a vaginal yeast infection

WARNINGS

Warnings

For vaginal use only.

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

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

ASK DOCTOR

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.
• vaginal yeast infections often (such as once a month or three 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

Do not use

• if you are allergic to any ingredient in this product

WHEN USING

When using this product

• do not use tampons, douiches, 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 complete relief, ask a doctor before using another product

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

• Adults and children 12 years or over:

​Vaginal Ointment: use at bedtime, read enclosed instructions for complete directions.

• to protect clothes, use panty liner
• fill applicator with FemiClear Vaginal Ointment (pink tube).
• lie down in bed. Insert applicator into vagina and inject Femiclear. Remain lying down to avoid leakage.
• discard applicator after use. DO NOT reuse.
• repeat on second night.

Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin outside the vagina (vulva) as needed.

• Children under 12 years: ask a doctor

STORAGE AND HANDLING

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
• do not purchase if carton is open
• Store at 68-77°F (20-25°C). If liquified, refrigerate 10 minutes to thicken.
• this 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.

INACTIVE INGREDIENT

Inactive ingredients

Vaginal Ointment: beeswax, essential oil (natural fragrance), oxygenated olive oil

Itch Relief: beeswax, colloidal oatmeal, essential oil (natural fragrance), oxygenated olive oil

QUESTIONS

Questions?

Call 512-401-3572 or visit FemiClear.com

Organicare, LLC, Austin, TX 78744, USA

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Made and Distributed by

OrganiCare®

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEMICLEAR   YEAST INFECTION TREATMENT
calendula, melaleuca, oleuropein, chamomilla kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71042-011

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-011-28	1 in 1 CARTON; Type 0: Not a Combination Product	11/12/2021

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 
calendula, melaleuca, oleuropein ointment

Product Information
Item Code (Source)	NDC: 71042-012
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
OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L)	OLEUROPEIN	3 [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
OLIVE OIL (UNII: 6UYK2W1W1E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-012-14	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		11/12/2021

Part 2 of 2

FEMICLEAR EXTERNAL ANTI-ITCH 
chamomilla, oleuropein ointment

Product Information
Item Code (Source)	NDC: 71042-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L)	OLEUROPEIN	3 [hp_X]  in 14 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	3 [hp_X]  in 14 g

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)
OATMEAL (UNII: 8PI54V663Y)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-013-14	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		11/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/12/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Organicare Nature's Science, LLC		044204745	manufacture(71042-011)