Label: MIRACLE GYN (4 TABLETS)- allantoin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55618-2008-1, 55618-2008-2, 55618-2008-3 - Packager: Haudongchun Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated August 22, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep out of reach of children
- Uses
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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.
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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
- Miracle GYN (4 Tablets)
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INGREDIENTS AND APPEARANCE
MIRACLE GYN (4 TABLETS)
allantoin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55618-2008 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 66 mg in 600 mg Inactive Ingredients Ingredient Name Strength .ALPHA.-D-GLUCOPYRANOSE (UNII: 5J5I9EB41E) MENTHA PIPERITA LEAF (UNII: A389O33LX6) CENTELLA ASIATICA (UNII: 7M867G6T1U) GINKGO (UNII: 19FUJ2C58T) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ANGELICA GIGAS ROOT (UNII: 32766B2FHX) SODIUM CHLORIDE (UNII: 451W47IQ8X) MAGNESIUM STEARATE (UNII: 70097M6I30) ALOE VERA LEAF (UNII: ZY81Z83H0X) Product Characteristics Color white Score no score Shape CAPSULE Size 14mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55618-2008-3 2 in 1 PACKAGE 08/22/2017 1 NDC:55618-2008-2 2 in 1 BLISTER PACK 1 NDC:55618-2008-1 600 mg in 1 CAPSULE; Type 0: Not a Combination Product 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 Business Operations Haudongchun Co., Ltd. 688479464 manufacture(55618-2008)
