Femiclear 2d Yeast Infection - Improved Formula

Femiclear 2d Yeast Infection - Improved Formula
SPL v6
SPL
SPL Set ID cfc2fb2b-f4a0-748b-e053-2995a90aaca4
Routes
VAGINAL TOPICAL
Published
Effective Date 2021-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (3 [hp_X]) Oleuropein Melaleuca Cajuputi Leaf Oil Matricaria Chamomilla
Inactive Ingredients
Olive Oil Lavender Oil Yellow Wax Oatmeal

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-11-12

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

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

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

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.
Section 50565-1

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

Section 50566-9

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
Section 50567-7

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
Section 50569-3

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
Section 50570-1

Do not use

  • if you are allergic to any ingredient in this product
Section 51727-6

Inactive ingredients

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

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

Section 51945-4

Section 53413-1

Questions?

Call 512-401-3572 or visit FemiClear.com

Organicare, LLC, Austin, TX 78744, USA

Section 53414-9

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

Section 55105-1

Purposes

Healing agent

Anti-yeast agent

Antimicrobial and healing agent

Anti-itch and inflammatory agent

Anti-microbial and healing agent

Section 55106-9

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


Structured Label Content

Indications and Usage (34067-9)

Uses

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

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.
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to any ingredient in this product
Section 51727-6 (51727-6)

Inactive ingredients

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

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Call 512-401-3572 or visit FemiClear.com

Organicare, LLC, Austin, TX 78744, USA

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Healing agent

Anti-yeast agent

Antimicrobial and healing agent

Anti-itch and inflammatory agent

Anti-microbial and healing agent

Section 55106-9 (55106-9)

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


Advanced Ingredient Data


Raw Label Data

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