Label: HYDRO H- arbutin solution
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Contains inactivated NDC Code(s)
NDC Code(s): 69422-5001-1 - Packager: General Bio 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 December 9, 2014
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
・Stop using the product when you have skin problems or the product disagrees with your skin
・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
・If the product gets into the eyes, don't rub but rinse with water.
・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRO H
arbutin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69422-5001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF) ARBUTIN 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYALURONIC ACID (UNII: S270N0TRQY) PREZATIDE COPPER (UNII: 6BJQ43T1I9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69422-5001-1 20 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/09/2014 Labeler - General Bio Co., Ltd. (688299527) Registrant - General Bio Co., Ltd. (688299527) Establishment Name Address ID/FEI Business Operations General Bio Co., Ltd. 688299527 manufacture(69422-5001)