FEMICLEAR 2 DAY GENTLE- 2 day yeast infection gentle ointment

FemiClear 2 Day Gentle by

Drug Labeling and Warnings

FemiClear 2 Day Gentle by is a Homeopathic medication manufactured, distributed, or labeled by OrganiCare Nature's Science, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active ingredients
Vaginal Ointment
Calendula 6X HPUS ............................................................................................... Healing agent
Melaleuca 6X HPUS........................................................................................... Anti-yeast agent
Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent
Itch Relief
Chamomilla 3X HPUS ............................................................... Anti-itch and inflammatory agent
Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent

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 a doctor before use if you have:

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 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

Do not use
 if you are allergic to any ingredient in this product

When using 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

Warnings (Cont.)

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, vomiting or
foul-smelling discharge

If pregnant or breast-feeding

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

Keep out of the reach of children

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

Directions

Directions
 Adults and children 12 years or over:
Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
complete directions.
 to protect clothes, use panty liner.
 fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the 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 - use other 1/2 of the pink tube
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
outside the vagina (vulva) as needed.
 Children under 12 years: ask a doctor

Other information

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° C – 25° C) If liquefied, 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 ingredients

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

Uses

-treats vaginal infections

-releaves external itching and irritation due to vaginal yeast inrfection

-relieves external itching and irritation due to vaginal yeast inrfection

Directions

Directions
 Adults and children 12 years or over:
Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
complete directions.
 to protect clothes, use panty liner.
 fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the 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 - use other 1/2 of the pink tube
Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
outside the vagina (vulva) as needed.
 Children under 12 years: ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEMICLEAR 2 DAY GENTLE 
2 day yeast infection gentle ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71042-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELALEUCA CAJUPUTI WHOLE (UNII: K62C66D9LN) (MELALEUCA CAJUPUTI WHOLE - UNII:K62C66D9LN)	MELALEUCA CAJUPUTI WHOLE	0.01 g  in 100 g
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H)	CALENDULA OFFICINALIS WHOLE	0.01 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)	88 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71042-029-14	1 in 1 CARTON	07/28/2023
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		07/28/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
OrganiCare Nature's Science, LLC		044204745	manufacture(71042-029)