Drug Facts
Active ingredients
Calendula HPUS 1X and
Hamamelis HPUS 6X:
each less than 1% w/w
Mae By Damiva
FDA Label NDC 69316-321
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Damiva Inc. for the product Mae By Damiva (NDC 69316-321). 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 drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Vaginal Discomfort
Indications & Usage
Uses: For soothing relief of vaginal discomfort, dryness, itching, odor and pain. These uses are based solely on usage in homeopathic medicine. This product has not been evaluated by the Food and Drug Administration for safety or efficacy.
Warnings
For vaginal use only.
Otc - Do Not Use
Do not use if you have an underlying gynecological medical condition or infection e.g. yeast or bacterial infection, sexually transmitted diseases, pelvic inflammatory disease, tenderness, swelling, discharge, chills, nausea, vomiting, rash or increased pain.
Otc - Ask Doctor
If symptoms persist or worsen, or if new symptoms appear, consult a doctor as these could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If you are pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
Store at 68-77 °F.
Dosage & Administration
Directions: Remove plastic wrap from ovule. Using a clean finger, insert one suppository vaginally as far as comfortable. Use as needed, or every 2 to 3 days, to a maximum of one ovule per day. May use at bedtime to prevent product leakage. Best results may occur after consecutive use of 10 ovules.
Inactive Ingredient
Inactive ingredients:
Garcinia indica, Invert Sugar, Sucrose, Theobroma cacao (<30% w/w)
Package Label.Principal Display Panel
100% natural
vaginal suppository.
Feel like a teenager again, but with better judgement.
mae by damiva
Homeopathic formula
10 ovule suppositories 1.9 g each. Net weight 19 g.
* Please review the disclaimer below.
