SPL v1
SPL
SPL Set ID 86c9c1a9-452b-4bae-a13e-723e4fc87eef
Route
VAGINAL
Published
Effective Date 2025-03-21
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 Whole (0.0025 g) Limosilactobacillus Fermentum
Inactive Ingredients
Poliglusam Hyaluronate Sodium Chamomile Olive Oil Amino Acids, Source Unspecified Collagen, Soluble, Fish Skin Turmeric Curcuma Zedoaria Root Pueraria Montana Var. Lobata Root

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-03-13

Description

Olive Extract (Oleuropein)  3X HPUS Hydrastis Canadensis         5X HPUS, Borax                               3X HPUS (Sodium Borate)  Calendula Officinalis          1X HPUS, Lactobacillus fermentum    0.0025%.

Purpose

Anti-microbal and healing agent


Medication Information

Purpose

Anti-microbal and healing agent

Description

Olive Extract (Oleuropein)  3X HPUS Hydrastis Canadensis         5X HPUS, Borax                               3X HPUS (Sodium Borate)  Calendula Officinalis          1X HPUS, Lactobacillus fermentum    0.0025%.

Uses

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

Section 50565-1

Warnings

For vaginal use only.

  • Do not use if you have never had a bacterial vaginosis infection diagnosed by a doctor.
  • Oinment may damage condoms and diaphragms and cause them to fail

When using this product

  • can be used in combination with other medications, please consult a healthcare professional 
  • 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
  • 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, addominal pain, fever, chills, nausea or vomtting
  • if pregnant or breast-feeding ask a healthcare professional before use
  • keep out of reach of children. If swallowed , get medical help or Contact a Poison Control Center right away 
Directions

Adults and children 12 years or over:

Use at bed time, read enclosed instructions for complete directions.

to protect cloths, use panty liner

lie down in bed. Insert applicator into vagina and inject ointment. Remain lying down to avoid leakage

discard applicator after use. DO NOT reuse.

children under 12 years : ask a doctor 

Product Label

Active Ingredient

Olive Extract (Oleuropein)  3X HPUS

Hydrastis Canadensis         5X HPUS,

Borax                               3X HPUS (Sodium Borate) 

Calendula Officinalis          1X HPUS,

Lactobacillus fermentum    0.0025%.

Other Information 
  • do not use if applicator wrappear is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured
  • store at 68° - 77° F (20° to 25° C) if liquefied, refrigerate 10minutes to thicken.
Inactive Ingredients

Chitosan, Collagen peptide, Sodium hyaluronate, Chamomile extract, Radix curcumae extract. Rhizome spaganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated Olive Oil, Amino acid.


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

Purpose

Anti-microbal and healing agent

Warnings

For vaginal use only.

  • Do not use if you have never had a bacterial vaginosis infection diagnosed by a doctor.
  • Oinment may damage condoms and diaphragms and cause them to fail

When using this product

  • can be used in combination with other medications, please consult a healthcare professional 
  • 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
  • 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, addominal pain, fever, chills, nausea or vomtting
  • if pregnant or breast-feeding ask a healthcare professional before use
  • keep out of reach of children. If swallowed , get medical help or Contact a Poison Control Center right away 
Directions

Adults and children 12 years or over:

Use at bed time, read enclosed instructions for complete directions.

to protect cloths, use panty liner

lie down in bed. Insert applicator into vagina and inject ointment. Remain lying down to avoid leakage

discard applicator after use. DO NOT reuse.

children under 12 years : ask a doctor 

Product Label (Product label)

Active Ingredient

Olive Extract (Oleuropein)  3X HPUS

Hydrastis Canadensis         5X HPUS,

Borax                               3X HPUS (Sodium Borate) 

Calendula Officinalis          1X HPUS,

Lactobacillus fermentum    0.0025%.

Other Information 
  • do not use if applicator wrappear is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured
  • store at 68° - 77° F (20° to 25° C) if liquefied, refrigerate 10minutes to thicken.
Inactive Ingredients (Inactive ingredients)

Chitosan, Collagen peptide, Sodium hyaluronate, Chamomile extract, Radix curcumae extract. Rhizome spaganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated Olive Oil, Amino acid.


Advanced Ingredient Data


Raw Label Data

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