Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 54b46411-0ff8-4b08-bf37-802b94acf5c1
Route
TOPICAL
Published
Effective Date 2023-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oleuropein (3 [hp_X]) Goldenseal (5 [hp_X]) Borate Ion (1 [hp_X]) Calendula Officinalis Flowering Top
Inactive Ingredients
Poliglusam Povidone-iodine Sodium Chamaemelum Nobile Flower Curcuma Kwangsiensis Root Sparganium Stoloniferum Root Curcuma Zedoaria Whole Olive Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-11-11

Description

Olive Extract (oleuropein)                      3X HPUS Hydrastis Canadensis                            5X HPUS Borax (Sodium Borate)                          3X HPUS Calendula Officinalis                              1X HPUS

Purpose

Anti-microbial and Healing agent


Medication Information

Purpose

Anti-microbial and Healing agent

Description

Olive Extract (oleuropein)                      3X HPUS Hydrastis Canadensis                            5X HPUS Borax (Sodium Borate)                          3X HPUS Calendula Officinalis                              1X HPUS

Uses

This product is designed to alleviate symptoms linked to recognized bacterial vaginosis infecfions, such as a pungent odor, excessive discharge, as well as discomfort and a burning sensation during urination.

Section 50565-1

Warnings
  • For vaginal use only.
  • Do not use if you have never had bacterial vaginosis infection diagnosed by a doctor.
  • Ointment may damage condoms and diaphragms, potentially leading to their Ineffectiveness.

When using this product:

  • If considering its use in conjunction with other medications, it is advisable to seek guidance from a healthcare professional.
  • Avoid the use of tampons, douches, spermicides, or other vaginal products. This is to prevent potential damage to condoms and diaphragms, which could result in a failure to provide adequate protection against pregnancy or sexually transmitted infections (STIs).
  • Refrain from engaging in vaginal intercourse
  • Be aware that there may be a slight uptick in vaginal burning, itching, or irritation
  • If relief is not attained, it is recommended to consult a doctor.

Stop use and ask a doctor if

  • symptoms do not get better in 3 days
  • symptoms persist for more than 7 days
  • You experience a rash or hives, abdominal pain, fever, chills, nausea, or vomiting.

If pregnant or breast-feedingask a healthcare professional before use.

Keep out of the reach of childrenIf swallowed, get medical help or contact Poison Control Center right away

Directions

Adults and children 12 years or over

Administer before bedtime, and consult the enclosed instructions for comprehensive guidance.

  • To safeguard clothing. employ a panty liner.
  • Recline on your bed. introduce the applicator into the vagina and dispense the ointment.Continue lying down to prevent any leakage.
  • After use, dispose of the applicator. DO NOT attempt to reuse it.
  • Children under 12 years: seek advice from a medical professional.
Product Label

Active Ingredient

Olive Extract (oleuropein)                      3X HPUS

Hydrastis Canadensis                            5X HPUS

Borax (Sodium Borate)                          3X HPUS

Calendula Officinalis                              1X HPUS

Other Information
  • Avoid usage if the applicator wrapper exhibits any tears, openings, or incomplete seals.
  • Do not use if the seal covering the tube opening has been punctured.
  • Keep it stored at a temperature range of 68°F - 77°F {20°C - 25°C]. In the event of liquefaction, refrigerate for 10 minutes to achieve a thicker consistency
  • This treatment consists of 7 doses. Typically, full symptom relief may not be achieved within just two days. Most women experience some improvement within two days. with complete relief typically occurring within seven days.
Inactive Ingredients

Chitosan, povidone-iodine, Sodum hyaluronate, Chamomile extract, Radix curcumae extract, Rhizome sparganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated Olive Oil


Structured Label Content

Uses

This product is designed to alleviate symptoms linked to recognized bacterial vaginosis infecfions, such as a pungent odor, excessive discharge, as well as discomfort and a burning sensation during urination.

Section 50565-1 (50565-1)

Purpose

Anti-microbial and Healing agent

Warnings
  • For vaginal use only.
  • Do not use if you have never had bacterial vaginosis infection diagnosed by a doctor.
  • Ointment may damage condoms and diaphragms, potentially leading to their Ineffectiveness.

When using this product:

  • If considering its use in conjunction with other medications, it is advisable to seek guidance from a healthcare professional.
  • Avoid the use of tampons, douches, spermicides, or other vaginal products. This is to prevent potential damage to condoms and diaphragms, which could result in a failure to provide adequate protection against pregnancy or sexually transmitted infections (STIs).
  • Refrain from engaging in vaginal intercourse
  • Be aware that there may be a slight uptick in vaginal burning, itching, or irritation
  • If relief is not attained, it is recommended to consult a doctor.

Stop use and ask a doctor if

  • symptoms do not get better in 3 days
  • symptoms persist for more than 7 days
  • You experience a rash or hives, abdominal pain, fever, chills, nausea, or vomiting.

If pregnant or breast-feedingask a healthcare professional before use.

Keep out of the reach of childrenIf swallowed, get medical help or contact Poison Control Center right away

Directions

Adults and children 12 years or over

Administer before bedtime, and consult the enclosed instructions for comprehensive guidance.

  • To safeguard clothing. employ a panty liner.
  • Recline on your bed. introduce the applicator into the vagina and dispense the ointment.Continue lying down to prevent any leakage.
  • After use, dispose of the applicator. DO NOT attempt to reuse it.
  • Children under 12 years: seek advice from a medical professional.
Product Label (Product label)

Active Ingredient

Olive Extract (oleuropein)                      3X HPUS

Hydrastis Canadensis                            5X HPUS

Borax (Sodium Borate)                          3X HPUS

Calendula Officinalis                              1X HPUS

Other Information (Other information)
  • Avoid usage if the applicator wrapper exhibits any tears, openings, or incomplete seals.
  • Do not use if the seal covering the tube opening has been punctured.
  • Keep it stored at a temperature range of 68°F - 77°F {20°C - 25°C]. In the event of liquefaction, refrigerate for 10 minutes to achieve a thicker consistency
  • This treatment consists of 7 doses. Typically, full symptom relief may not be achieved within just two days. Most women experience some improvement within two days. with complete relief typically occurring within seven days.
Inactive Ingredients

Chitosan, povidone-iodine, Sodum hyaluronate, Chamomile extract, Radix curcumae extract, Rhizome sparganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated Olive Oil


Advanced Ingredient Data


Raw Label Data

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