FDA Label for Olive Extract, Calendula, Melaleuca
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Olive Extract, Calendula, Melaleuca Product Label
The following document was submitted to the FDA by the labeler of this product Organicare Nature's Science, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by
OrganiCare®
Austin, TX 78744
Made in Italy
Otc - Active Ingredient
Active ingredients
Calendula 3X HPUS
Melaleuca 3X HPUS
Olive Extract 2X HPUS
Otc - Purpose
Purposes
Healing Agent
Anti-Yeast Agent
Antimicrobial and Healing Agent
Indications & Usage
Uses
See your doctor if this is the first time you have vaginal itching and discomfort to find out if you have a vaginal yeast infection.
- Treats repeat vaginal yeast infections
- To relieve external itching and irritation due to a repeat vaginal yeast infection
Warnings
Warnings
For vaginal use only.
FemiClear may damage condoms and diaphragms and cause them to fail.
Otc - Ask Doctor
Ask a doctor before use if you
- Have 1 or more of the following: abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge
- Get vaginal yeast infections often (such as once a month or three in 6 months)
- May have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
- Are under 12 years of age.
Otc - When Using
When using this product
- Do not have vaginal intercourse
- Do not use tampons, douiches, spermicides, or other vaginal products
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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
- Before use at bedtime, read enclosed instructions for complete directions.
- Adults and children 12 years and older:
- Refrigerate Vaginal Ointment for 20 minutes immediately before use.
- To protect clothes, use panty liner.
- Fill applicator with FemiClear Vaginal Ointment as shown.
- Lie down in bed. Insert applicator into vagina and inject Femiclear. Remain lying down to avoid leakage. Repeat on second night. Discard applicator after each use.
- External Itch Ointment: Squeeze a small amount of ointment onto your fingertip. Apply the ointment onto the itchy, irritated skin outside the vagina. Use as needed.
- Children under 12 years old: ask a doctor
Storage And Handling
Other information
- Store at 68-77°F (20-25°C)
- if liquified, refrigerate 20 minutes to thicken
Inactive Ingredient
Inactive ingredients
oxygenated olive oil, pure essential oil (lavender)
Otc - Questions
Questions?
Call 512-401-3572 or visit FemiClear.com
Package Label.Principal Display Panel
No Artificial Antifungal Drugs or Chemicals
FemiClear™
Yeast Infection Treatment
All-Natural and Organic
Homeopathic Medicine
Shortest Effective Remedy
2 Day Dose
1 tubes, Net Wt. 0.5 oz (14.2 g) each, Total Wt. 1 oz (28.4 g)
* Please review the disclaimer below.