FemiClear Yeast Infection

Manufacturer
Organicare Nature's Science, LLC
Effective date
2022-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:21

Label at a glance#

ProductFemiClear Yeast Infection 2 Day Dose
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, OLEUROPEIN, MELALEUCA CAJUPUTI LEAF OIL, MATRICARIA CHAMOMILLA
Label structure18 sections

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 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Vaginal Ointment

Calendula 6X HPUS

Melaleuca 6X HPUS

Olive Extract (Oleuropein) 3X HPUS

Itch Relief

Chamomilla 3X HPUS

Olive Extract (Oleuropein) 3X HPUS

OTC - PURPOSE SECTION

Purposes

Healing agent

Anti-yeast agent

Antimicrobial and healing agent

Anti-itch and inflammatory agent

Anti-microbial and healing agent

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to any ingredient in this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms do not improve in 3 days
  • symptoms remain after 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling discharge

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years or over:

​Vaginal Ointment (pink tube): 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 SECTION

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 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 INGREDIENT SECTION

Inactive ingredients

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

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

OTC - QUESTIONS SECTION

Questions?

Call 512-401-3572 or visit femiclear.com

Organicare, LLC, Austin, TX 78744, USA

SPL UNCLASSIFIED SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA!

FemiClear® YEAST INFECTION

2 DAY DOSE

GENTLE RELIEF FORMULA

MADE WITH ORGANIC INGREDIENTS

HOMEOPATHIC MEDICINE

2 TUBES: NET WT 0.5 OZ (14.2G) EACH, TOTAL NET WT 1.0 OZ (28.8G)

FEM_GentleRelief_cartonPDPFEM_GentleRelief_cartonPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71042-031-282024-01-30C16284748780-11030e365-3560-111a-e063-dadaa90a10e2FEMICLEAR YEAST INFECTION - NEW FORMULA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71042-031-28FemiClear Yeast Infection2 Day Dose1 in 1 CARTONKIT11
71042-034-14FemiClear Yeast Infection2 Day Dose14 g in 1 TUBEOINTMENT14 g6 [hp_X] in 14g1
71042-035-14FemiClear Yeast Infection2 Day Dose14 g in 1 TUBEOINTMENT14 g3 [hp_X] in 14g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71042-031FEMICLEAR YEAST INFECTION 2 DAY DOSE (CALENDULA, MELALEUCA, OLEUROPEIN, CHAMOMILLA) KIT [ORGANICARE NATURE'S SCIENCE, LLC]1Legacy NDC, 3 package rows20220503_ddbbb12e-0c73-5863-e053-2a95a90a717c.zip
71042-034FEMICLEAR YEAST INFECTION 2 DAY DOSE (CALENDULA, MELALEUCA, OLEUROPEIN, CHAMOMILLA) KIT [ORGANICARE NATURE'S SCIENCE, LLC]1Unmatched20220503_ddbbb12e-0c73-5863-e053-2a95a90a717c.zip
71042-035FEMICLEAR YEAST INFECTION 2 DAY DOSE (CALENDULA, MELALEUCA, OLEUROPEIN, CHAMOMILLA) KIT [ORGANICARE NATURE'S SCIENCE, LLC]1Unmatched20220503_ddbbb12e-0c73-5863-e053-2a95a90a717c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71042-03171042-031-28
71042-03471042-034-14
71042-03571042-035-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ddbbb12e-0c72-5863-e053-2a95a90a717cddbbb12e-0c73-5863-e053-2a95a90a717c2022-04-28WarningsExact identifier
spl id: ddbbb12e-0c72-5863-e053-2a95a90a717c
spl set id: ddbbb12e-0c73-5863-e053-2a95a90a717c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.