Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 43505966-6131-459a-9858-aaeb25cdd7dd
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]) Calendula Officinalis Flowering Top
Inactive Ingredients
Water Hyaluronate Sodium .alpha.-tocopherol Acetate Povidone-iodine Carbomer Homopolymer, Unspecified Type Sodium Hydroxide Edetate Sodium Hops Olive Oil Avocado Oil Cnidium Monnieri Fruit Taraxacum Mongolicum Whole

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-11-11

Description

Olive Extract (oleuropein) 3X HPUS                 Moisturing and Healing Agent Calendula Officinalis         3X HPUS                 Anti-microbial and Healing agent


Medication Information

Description

Olive Extract (oleuropein) 3X HPUS                 Moisturing and Healing Agent Calendula Officinalis         3X HPUS                 Anti-microbial and Healing agent

Uses

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

Section 55105-1

Warnings
  • For vaginal use only.
  • If pregnant or breast-feeding ask a healthcare professional before use.
  • Keep out of the reach of childrenIf swallowed, get medical help or contact Poison Control Center right away.
  • For adults only. Do not use it on children.
  • If vaginal irritation occurs, stop using. If symptoms persist, contact your physician.
  • Store in dry and cool place at 2°-30°C 
Directions

For individuals aged 12 and older:

  • Remove the applicator from the sealed wrapper by tearing the easy-open notch. DO NOT open the applicator at this time. Grip the applicator firmly by the thick end. Shake down to ensure that the contents are at the thin end of the applicator.
  • Bend the thin pointed end of the applicator back and forth repeatedly. Snap off the thin pointed end of the applicator and discard the tip.
  • DO NOT use scissors or tools to cut the applicator tip
  • Bend your knees while sitting, standing or lying on your back and gently insert the open end of the applicator right into the vagina.
  • Firmly press the thick end of the applicator to deposit the gel.
  • Remove the applicator and discard in waste container.
Product Label

Other Information

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

Purified water, povidone-iodine, Hyaluronic Acid, Tocopherol Acetate (vitamin E), Carbomer, Sodium Hydroxideb, Sodium Edetate, Hop Extract, Organic olive oil, Organic Avocado oil, Fructus Cnidii Extract, Taraxacum Mongolicum Extract

Active Ingredient     

Olive Extract (oleuropein) 3X HPUS                 Moisturing and Healing Agent

Calendula Officinalis         3X HPUS                 Anti-microbial and Healing agent


Structured Label Content

Uses

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

Section 55105-1 (55105-1)

Warnings
  • For vaginal use only.
  • If pregnant or breast-feeding ask a healthcare professional before use.
  • Keep out of the reach of childrenIf swallowed, get medical help or contact Poison Control Center right away.
  • For adults only. Do not use it on children.
  • If vaginal irritation occurs, stop using. If symptoms persist, contact your physician.
  • Store in dry and cool place at 2°-30°C 
Directions

For individuals aged 12 and older:

  • Remove the applicator from the sealed wrapper by tearing the easy-open notch. DO NOT open the applicator at this time. Grip the applicator firmly by the thick end. Shake down to ensure that the contents are at the thin end of the applicator.
  • Bend the thin pointed end of the applicator back and forth repeatedly. Snap off the thin pointed end of the applicator and discard the tip.
  • DO NOT use scissors or tools to cut the applicator tip
  • Bend your knees while sitting, standing or lying on your back and gently insert the open end of the applicator right into the vagina.
  • Firmly press the thick end of the applicator to deposit the gel.
  • Remove the applicator and discard in waste container.
Product Label (Product label)

Other Information (Other information)

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

Purified water, povidone-iodine, Hyaluronic Acid, Tocopherol Acetate (vitamin E), Carbomer, Sodium Hydroxideb, Sodium Edetate, Hop Extract, Organic olive oil, Organic Avocado oil, Fructus Cnidii Extract, Taraxacum Mongolicum Extract

Active Ingredient     

Olive Extract (oleuropein) 3X HPUS                 Moisturing and Healing Agent

Calendula Officinalis         3X HPUS                 Anti-microbial and Healing agent


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)