Miracle Gyn (10 Tablets)
FDA Label NDC 55618-2003

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 (10 Tablets) (NDC 55618-2003). 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 ingredients, purpose, keep out of reach of children, uses, warnings, directions & dosage, inactive ingredients, miracle gyn (10 tablets), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Allantoin (11%)

Purpose

Vaginal skin protectant

Keep Out Of Reach Of Children

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 pregnant, hypersensitivity to any of the ingredients, scars on vagina, an allergic reaction or pain.

When using this product
 Do not use during menstruation.
 Use clean underwear.
 Do not use tampons, douches, condoms, feminine cleansers, 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 7 days
 You get rashes or hives, abdominal pain, fever, chills, nausea, vomiting or foul-smelling vaginal odor or discharge.

If pregnant or breast-feeding, ask a health professional before use.

Directions & Dosage

 Use it at bedtime preferably or during daytime without dynamic activites.
 Wash your finger and insert 2 pills into the vagina with first two knuckles 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.

 This product is for adults and children age of 4 and up.
 Use 2 tablets at a time 2-4 consecutive days until symptoms are relieved.
 After then, keep using 2 tablets every week

Other Information
 Store at cool temperature and dry place

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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