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ORGANIC AND PLANT-BASED VULVOVAGINAL CARE

ORGANIC AND PLANT-BASED VULVOVAGINAL CARE

Approved
Approval ID

3754fddb-82f1-9ca7-e063-6294a90ab3da

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 11, 2025

Manufacturers
FDA

MOMOTARO APOTHECA LLC

DUNS: 107377060

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Echinacea purpurea, Wood creosote, Thuja occidentalis leafy twig

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83385-001
Product Classification
G
Generic Name
Echinacea purpurea, Wood creosote, Thuja occidentalis leafy twig
Product Specifications
Route of AdministrationVAGINAL
Effective DateJune 11, 2025
FDA Product Classification

INGREDIENTS (10)

JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
BERBERIS AQUIFOLIUM ROOT BARKInactive
Code: VZJ9F3C3SB
Classification: IACT
ECHINACEA PURPUREAActive
Quantity: 12 [hp_X] in 1 1
Code: QI7G114Y98
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 12 [hp_X] in 1 1
Code: 1NT28V9397
Classification: ACTIB
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
COCOA BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WOOD CREOSOTEActive
Quantity: 12 [hp_X] in 1 1
Code: 3JYG22FD73
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/11/2025

Carton

Pouch

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/11/2025

Uses

For the relief of symptoms associated with vaginal yeast infection, including:

  • irritation
  • burning
  • itching
  • discharge.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/11/2025

Active ingredients
Echinacea purpurea 12X HPUS
Kreosotum 12X HPUS
Thuja occidentalis 12X HPUS

Purpose

Purpose

Relieve symptoms of vaginal yeast infection

WARNINGS SECTION

LOINC: 34071-1Updated: 6/11/2025

Warnings

For vaginal use only. Not for oral consumption.

Stop use and ask a doctor if:

  • You have symptoms of pelvic inflammatory disease (PID) or a sexually transmitted infection (STI)
  • Symptoms last more than 7 days.
  • • You get a rash or hives, abdominal pain, fever, chills, nausea, vomitting, or foul-smelling vaginal discharge.

If pregnant or breast-feeding, consult a licensed medical professional prior to use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask a doctor before use if you have

• Lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling discharge. You may have a more serious condition. • Recurring vaginal yeast infections (once a month). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • You have an STI (sexually transmitted infection) or PID (pelvic inflammatory disease).

• You have frequent and painful urination.

When using this product

  • Do not have vaginal intercourse (sex).
  • Do not use tampons, douches, spermicides, or other intravaginal products.
  • Do not use condoms or diaphragms. They may be damaged by this product and fail to prevent pregnancy or transmission of sexually transmitted infections (STls)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/11/2025

Directions

Directions For individuals 13 years or older. Use only as directed. Remove one suppository from its wrapper. With clean hands, use index finger to insert suppository into the vagina. Use suppository once or twice daily as symptoms require for up to seven days. Leakage and discharge is normal while using this product. Can be used with organic liner to protect your underwear.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/11/2025

Other information

Other Information

• Suppositories are not contraceptives and should not be used to prevent pregnancy.

• Do not use if seal is broken. • Store at room temperature, can be refrigerated before use. Expiration date and lot number are found on the bottom of the box

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/11/2025

Inactive Ingredients

Beeswax (Cera Alba), Calendula Flower (calendula officinalis) Extract, Cocoa Butter (Theobroma cacao), Coconut Oil (Cocos nucifera), Ethyl Alcohol, Jojoba Oil (Simmondsia chinensis), Oregon Grape Root (Mahonia aquafolium) Extract, Tea Tree Oil (Melaleuca alternaifolia)".

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/11/2025

Questions or comments?

1-(833)-777-8462

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/11/2025

Do not use

Do not use if you have never had vaginal yeast infection diagnosed by a doctor. A yeast infection can have similar symptoms to bacterial vaginosis, so if this is the first time you are experiencing symptoms seek medical evaluation from your doctor.

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ORGANIC AND PLANT-BASED VULVOVAGINAL CARE - FDA Drug Approval Details