Label: MIRACLE GYN (2 TABLETS)- allantoin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55618-2002-1, 55618-2002-2, 55618-2002-3 - Packager: Haudongchun Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 24, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
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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.
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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 weekOther Information
Store at cool temperature and dry place - Inactive Ingredients
- Miracle GYN (2 tablets)
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INGREDIENTS AND APPEARANCE
MIRACLE GYN (2 TABLETS)
allantoin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55618-2002 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.11 in 600 mg Inactive Ingredients Ingredient Name Strength Sodium Chloride (UNII: 451W47IQ8X) .ALPHA.-D-GLUCOPYRANOSE (UNII: 5J5I9EB41E) MAGNESIUM STEARATE (UNII: 70097M6I30) ALOE VERA LEAF (UNII: ZY81Z83H0X) GINKGO (UNII: 19FUJ2C58T) MENTHA PIPERITA LEAF (UNII: A389O33LX6) CENTELLA ASIATICA (UNII: 7M867G6T1U) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ANGELICA GIGAS ROOT (UNII: 32766B2FHX) 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:55618-2002-3 1 in 1 PACKAGE 07/06/2016 1 NDC:55618-2002-2 2 in 1 BLISTER PACK 1 NDC:55618-2002-1 600 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 07/06/2016 Labeler - Haudongchun Co., Ltd. (688479464) Registrant - Haudongchun Co., Ltd. (688479464) Establishment Name Address ID/FEI Business Operations Haudongchun Co., Ltd. 688479464 manufacture(55618-2002)