ORGANIC AND PLANT-BASED VULVOVAGINAL CARE

Manufacturer
MOMOTARO APOTHECA LLC
Effective date
2025-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:04

Label at a glance#

ProductORGANIC AND PLANT-BASED VULVOVAGINAL CARE
Active ingredientECHINACEA PURPUREA, THUJA OCCIDENTALIS LEAFY TWIG, WOOD CREOSOTE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Purpose

Relieve symptoms of vaginal yeast infection

INDICATIONS & USAGE SECTION

Uses

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

  • irritation
  • burning
  • itching
  • discharge.

Warnings

WARNINGS SECTION

For vaginal use only. Not for oral consumption.

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ASK DOCTOR SECTION

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.

OTC - WHEN USING SECTION

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)

Directions

DOSAGE & ADMINISTRATION SECTION

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 information

OTHER SAFETY 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 Ingredients

INACTIVE INGREDIENT SECTION

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)".

Questions or comments?

OTC - QUESTIONS SECTION

1-(833)-777-8462

Do not use

OTC - DO NOT USE SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

PouchPouch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83385-001-01ORGANIC AND PLANT-BASED VULVOVAGINAL CARE1 in 1 PACKETSUPPOSITORY11
83385-001-01ORGANIC AND PLANT-BASED VULVOVAGINAL CARE14 in 1 CARTONSUPPOSITORY141
83385-001-02ORGANIC AND PLANT-BASED VULVOVAGINAL CARE1 in 1 PACKETSUPPOSITORY11
83385-001-02ORGANIC AND PLANT-BASED VULVOVAGINAL CARE3 in 1 POUCHSUPPOSITORY31

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83385-00183385-001-01, 83385-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORGANIC AND PLANT-BASED VULVOVAGINAL CAREECHINACEA PURPUREA, WOOD CREOSOTE, THUJA OCCIDENTALIS LEAFY TWIGMOMOTARO APOTHECA LLC3754fddb-82f1-9ca7-e063-6294a90ab3da2025-06-11WarningsExact identifier
ndc (package): 83385-001-02
ndc (package): 83385-001-01
ndc (product): 83385-001
ndc11 (package): 83385000102
ndc11 (package): 83385000101
spl id: 3754fdee-f899-c507-e063-6394a90adffc
spl set id: 3754fddb-82f1-9ca7-e063-6294a90ab3da

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.