FEMICLEAR YEAST INFECTION- femiclear 2 day simple ointment

FemiClear Yeast Infection by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Calendula 2X HPUS

Melaleuca 3X HPUS

Olive Extract 3X HPUS

Purpose

Healing agent

Anti-yeast agent

Anti-microbial and healing agent

Uses

Treats vaginal yeast infections

Warnings

For vaginal use only.

FemiClear 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 abdomen, back or shoulder pain, fever 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 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 complete relief, ask a doctor before using another product

Stop use and ask a doctor if

symproms do not get better in 3 days

symptoms last more than 7 days

you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting or foul-smelling discharge

If pregnant or breastfeeding

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.

Directions

Adults and children 12 years or over:

Vaginal Ointment: use at bed time, read enclosed instructions for complete directions.

to protect clothes, use panty liner.

fill applicator with Vaginal Ointment - use one of the tubes

lie down in bed. Insert applicator into vagina and inject FemiClear. Remain laying down to avoid leakage.

discard applicator after use. DO NOT reuse.

repeat on second night - use other 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

Other Information

Store at 68-77 F (20 C - 25 C)

If liquified, refrigerate 10 minutes to thicken.

Inactive ingredients

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

Questions?

Call 512.401.3572 or vist femiclear.com. OrganiCare, LLC, Austin TX 78744, USA

SPL UNCLASSIFIED SECTION

Made and Distributed by

OrganiCare

Austin, TX 78744 USA

PRINCIPAL DISPLAY PANEL

FemiClear

Yeast Infection

Relieves

Itching

Irritation

Discharge

Kills >99%

of tough to treat

yeast*

*Laboratory testing (non-human/non-animal)

Homeopathic Medicine

2 Day Dose

2 Tubes; Net Wt 0.25 oz

(7.1G) each, Total Net Wt 0.5 oz (14.2G)

INGREDIENTS AND APPEARANCE

FEMICLEAR YEAST INFECTION 
femiclear 2 day simple ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71042-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H)	CALENDULA OFFICINALIS WHOLE	1 kg  in 1 kg
CAJUPUT OIL (UNII: J3TO6BUQ37) (CAJUPUT OIL - UNII:J3TO6BUQ37)	CAJUPUT OIL	0.1 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
PEAR (UNII: 2ZN8DWC0YF)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-026-14	1 in 1 CARTON	01/17/2023
1		0.0142 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		01/17/2023

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(71042-026)