Label: QUEEN PURECELL WHITENING 3-STEP MASK- niacinamide, adenosine kit
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Contains inactivated NDC Code(s)
NDC Code(s): 71609-0005-1, 71609-0005-2, 71609-0006-1, 71609-0007-1, view more71609-0008-1 - Packager: Purecell Korea 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 7, 2017
If you are a consumer or patient please visit this version.
- 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
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
QUEEN PURECELL WHITENING 3-STEP MASK
niacinamide, adenosine kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71609-0005 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71609-0005-2 4 in 1 PACKAGE 06/01/2017 1 NDC:71609-0005-1 1 in 1 POUCH; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 POUCH 1.5 mL Part 2 1 POUCH 30 g Part 3 1 POUCH 1.5 g Part 1 of 3 QUEEN PURECELL WHITENING FAST REPAIRING AMPOULE
niacinamide, adenosine liquidProduct Information Item Code (Source) NDC:71609-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 mL ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71609-0008-1 1.5 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2017 Part 2 of 3 QUEEN PURECELL WHITENING AND REPAIR MASK SHEET
niacinamide, adenosine patchProduct Information Item Code (Source) NDC:71609-0006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 g ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71609-0006-1 30 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2017 Part 3 of 3 QUEEN PURECELL WHITENING REPAIR FINALIZING
niacinamide, adenosine creamProduct Information Item Code (Source) NDC:71609-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 g ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71609-0007-1 1.5 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2017 Labeler - Purecell Korea Co., Ltd. (694667185) Registrant - Purecell Korea Co., Ltd. (694667185) Establishment Name Address ID/FEI Business Operations Purecell Korea Co., Ltd. 694667185 label(71609-0005) , pack(71609-0005) , manufacture(71609-0005)
