ORGANIC AND PLANT-BASED VULVOVAGINAL CARE
ORGANIC AND PLANT-BASED VULVOVAGINAL CARE
3754fddb-82f1-9ca7-e063-6294a90ab3da
HUMAN OTC DRUG LABEL
Jun 11, 2025
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
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
For the relief of symptoms associated with vaginal yeast infection, including:
- irritation
- burning
- itching
- discharge.
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Echinacea purpurea 12X HPUS
Kreosotum 12X HPUS
Thuja occidentalis 12X HPUS
Purpose
Purpose
Relieve symptoms of vaginal yeast infection
WARNINGS SECTION
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
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
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
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
Questions or comments?
1-(833)-777-8462
OTC - DO NOT USE SECTION
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.