Active Ingredient
Allantoin (11%)
Miracle Gyn (4 Tablets)
FDA Label NDC 55618-2008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haudongchun Co., Ltd. for the product Miracle Gyn (4 Tablets) (NDC 55618-2008). 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, uses, warnings, directions, inactive ingredients, miracle gyn (4 tablets), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Vaginal skin protectant
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control right away. (1-800-222-1222)
Uses
- Relieves the following symptoms: vaginal irritation, itching and burning, odor, vaginal dryness
Warnings
For vaginal use only
Do not use if you have/are pregnat, hypersensitivity to any pain.
When using this product
- do not use during menstruation
- use clean underwear
- do not use tampons, douches, condoms, feminine clenasers, or other vaginal products
- do not eat or swallow
Stop use and ask a doctor if
- symptoms get worsen or do not get better
- symptoms last more than 7days
- you get rashes or hives, abdominal pain, fever, chillis, nausea, vomiting or foul-smelling vaginal odor or discharge
Store at room tmperature and in a dry place.
Directions
- Use it at bedtime preferably or during daytime without dynamic activites.
- Wash your finger and insert 2 pills into the vagina with first two knuckels of a finger. It will take 20-30 minutes until the pills are dissolved to relieve the symptoms and clean the vagina.
- Do not use within 6 hours prior to vaginal intercourse.
Dosage
- This product is for adults and children age of 4 and up.
- Use 2 tablets at a time 2-4 consecutive days until symptom are relieved.
- After then, keep using 2 tablets every week.
Inactive Ingredients
Sodium Chloride, Soluble Collagen, Glucose, Magnesium Stearate, Aloe Barbadensis Leaf Extract, Cereus Grandiflorus (Cactus) Extract, Ginkgo Biloba Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Centella Asiatica Extract, Sophora Flavescens Root Extract, Angelica Gigas Root Extract
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