Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6112e199-b7dd-42e1-9004-f07a9bcd221d
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 intended to relieve symptoms associated with known yeast infections, including fishy odor, excess discharge, irritation and burning while urinating.

Warnings
  • For vaginal use only.
  • Do not use if you have never had vaginal infection diagnosed by a doctor.
  • Ointment may damage condoms and diaphragms and cause them to fail.

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.
  • bacterial vaginosis 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 if you are allergic to any ingredient in 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 relief, consult a doctor

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 or vomiting

  • If pregnant or breast-feeding ask a healthcare professional before use.
  • Keep out of the reach of children If swallowed, get medical help or contact Poison Control Center right away
Directions

For individuals aged 12 and older:

  • Utilize this product before bedtime; refer to the enclosed instructions for comprehensive guidance. 
  • Place a panty liner in your underwear to prevent any potential leakage. 
  • While lying in bed, gently insert the applicator into the vagina and administer the ointment. Stay in a reclined position to minimize the risk of leakage. 
  • Dispose of the applicator after a single use.

Children under 12 years: Ask a doctor

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 is damaged, opened, or not fully sealed.

• Do not use if the seal over the tube opening has been pierced.

• Store between 68°-77°F (20°C - 25°C). If the product liquefies, refrigerate it for 10 minutes to regain its thickness

Please note that this treatment consists of 7 doses. While many women may not experience complete symptom relief within just two days, most will notice some improvement in that timeframe and should expect complete relief within seven days.

Inactive Ingredients

Chitosan, povidone-iodine, Sodium hyaluonate, Chammomile Extract, Radix Curcumae extract, Rhizoma Sparganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated olive oil


Structured Label Content

Uses

This product is intended to relieve symptoms associated with known yeast infections, including fishy odor, excess discharge, irritation and burning while urinating.

Purpose

Anti-microbial and Healing agent

Warnings
  • For vaginal use only.
  • Do not use if you have never had vaginal infection diagnosed by a doctor.
  • Ointment may damage condoms and diaphragms and cause them to fail.

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.
  • bacterial vaginosis 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 if you are allergic to any ingredient in 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 relief, consult a doctor

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 or vomiting

  • If pregnant or breast-feeding ask a healthcare professional before use.
  • Keep out of the reach of children If swallowed, get medical help or contact Poison Control Center right away
Directions

For individuals aged 12 and older:

  • Utilize this product before bedtime; refer to the enclosed instructions for comprehensive guidance. 
  • Place a panty liner in your underwear to prevent any potential leakage. 
  • While lying in bed, gently insert the applicator into the vagina and administer the ointment. Stay in a reclined position to minimize the risk of leakage. 
  • Dispose of the applicator after a single use.

Children under 12 years: Ask a doctor

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 is damaged, opened, or not fully sealed.

• Do not use if the seal over the tube opening has been pierced.

• Store between 68°-77°F (20°C - 25°C). If the product liquefies, refrigerate it for 10 minutes to regain its thickness

Please note that this treatment consists of 7 doses. While many women may not experience complete symptom relief within just two days, most will notice some improvement in that timeframe and should expect complete relief within seven days.

Inactive Ingredients

Chitosan, povidone-iodine, Sodium hyaluonate, Chammomile Extract, Radix Curcumae extract, Rhizoma Sparganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated olive oil


Advanced Ingredient Data


Raw Label Data

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