Label: DR. GLODERM TABRX WHITENING- niacinamide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71342-0012-1 - Packager: DR.GLODERM
- Category: HUMAN OTC DRUG LABEL
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 March 28, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight4. Use as avoiding eye areas.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. GLODERM TABRX WHITENING
niacinamide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71342-0012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2.14 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71342-0012-1 45 g in 1 JAR; Type 0: Not a Combination Product 03/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2017 Labeler - DR.GLODERM (694773267) Registrant - DR.GLODERM (694773267) Establishment Name Address ID/FEI Business Operations SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory 689851701 manufacture(71342-0012) Establishment Name Address ID/FEI Business Operations DR.GLODERM 694773267 label(71342-0012)