Otc - Active Ingredient
Active ingredients
Echinacea purpurea 12X HPUS
Kreosotum 12X HPUS
Thuja occidentalis 12X HPUS
The following Structured Product Label (SPL) was submitted to the FDA by Momotaro Apotheca Llc for the product Organic And Plant-based Vulvovaginal Care (NDC 83385-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Echinacea purpurea 12X HPUS
Kreosotum 12X HPUS
Thuja occidentalis 12X HPUS
Purpose
Relieve symptoms of vaginal yeast infection
Uses
For the relief of symptoms associated with vaginal yeast infection, including:
For vaginal use only. Not for oral consumption.
Stop use and ask a doctor if:
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
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
• 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
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)".
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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.
* Please review the disclaimer below.