Active Ingredient
Allantoin
Miracle Gyn
FDA Label NDC 55618-2001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ha U Dong Chun for the product Miracle Gyn (NDC 55618-2001). 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 active ingredient, purpose, keep out of reach of children, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Relives the following symptoms; yeast infection, vaginal itching and irritation, vaginal dryness and odor, menstrual cramps, urinary incontinence, vaginal tightness.
Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
This product is to be used in the vagina. Use it at bedtime, or during the day without dynamic activities. Insert the pills into your vagina with first two knuckles of your finger. During the 20 to 30 minutes the pills are melted and they are effective in improving vaginal health.
Warnings
- Do not use during pregnant, breast-feeding, or menstrual cycle.
- Keep this product out of reach of children under 3 years old.
Dosage & Administration
For vaginal use only.
Other Safety Information
- Keep product out of direct sunlight, high temperature and humidity.
- Store in a cool dry place.
- Any items past the expiration date, spoiled, or damaged in transit can be exchanged where you originally purchased the item.
Inactive Ingredient
Sodium chloride, collagen, glucose, magnesium stearate, aloe extract, opuntia ficus-indica extract, menthe aryensis extract, centella asiatica extract, sophora flavescens aiton extract, angelica acutiloba extract
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