Miracle GYN (4 Tablets): Package Insert and Label Information

MIRACLE GYN (4 TABLETS)- allantoin tablet
Haudongchun Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredient

Allantoin (11%)

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

Miracle GYN (4 Tablets)

miracle gyn 4 tablets
(click image for full-size original)

MIRACLE GYN (4 TABLETS)
allantoin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55618-2008
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN (ALLANTOIN) ALLANTOIN 66 mg in 600 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-D-GLUCOPYRANOSE
MENTHA PIPERITA LEAF
CENTELLA ASIATICA
GINKGO
SOPHORA FLAVESCENS ROOT
ANGELICA GIGAS ROOT
SODIUM CHLORIDE
MAGNESIUM STEARATE
ALOE VERA LEAF
Product Characteristics
Color white Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55618-2008-3 2 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK (55618-2008-2)
1 NDC:55618-2008-2 2 CAPSULE in 1 BLISTER PACK This package is contained within the PACKAGE (55618-2008-3) and contains a CAPSULE (55618-2008-1)
1 NDC:55618-2008-1 600 mg in 1 CAPSULE This package is contained within a BLISTER PACK (55618-2008-2) and a PACKAGE (55618-2008-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/22/2017
Labeler — Haudongchun Co., Ltd. (688479464)
Registrant — Haudongchun Co., Ltd. (688479464)
Establishment
Name Address ID/FEI Operations
Haudongchun Co., Ltd. 688479464 manufacture (55618-2008)

Revised: 08/2017 Haudongchun Co., Ltd.

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