Label: VIVIDLY BRILLIANT PERFECTING- hydroquinone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68634-051-01 - Packager: AMCOL Health & Beauty Solutions, Inc. DBA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 3, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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Directions:
Apply a single pump to face in the evening. If you have never used a retinol product before, begin by limiting use to twice a week, gradually increasing frequency to every other night, and then advancing to each evening or as tolerated. Mild redness, peeling and irritation is expected when using this product.
- INDICATIONS & USAGE
- Caution:
- Active Ingredients:
- PURPOSE
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Inactive Ingredients:
Water, Caprylic/Capric, Triglyceride, Cetearyl Alcohol, Glycerin, Polysorbate 60, Dimethicone, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, C10-30 Cholesterol/Lanosterol Esters, Cetyl Ricinoleate, Cetyl Alcohol, Benzyl Alcohol, Polyacrylamide, Cetyl Phosphate, Sodium Metabisulfite, TEA-Stearate, Phenoxyethanol, Magnesium Aluminum Silicate, Cyclopentasiloxane, Triethanolamine, C13-14 Isoparaffin, PEG-10 Soy Sterol, Cyclohexasiloxane, Disodium EDTA, Methylparaben, Retinol, Polysorbate 20, Laureth-7, Bisabolol, Ascorbic Acid, Tocopheryl Acetate, BHT, Ascorbyl Palmitate, Propyl Gallate
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150609
AMCOL Health & Beauty Solutions, Inc. DBA
301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com
lauren.haase@amcol.com - Principal Display Panel - Carton Label
- Principal Display Panel - Bottle Label
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INGREDIENTS AND APPEARANCE
VIVIDLY BRILLIANT PERFECTING
hydroquinone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68634-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE) hydroquinone 40 g in 2 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) medium-chain triglycerides (UNII: C9H2L21V7U) cetostearyl alcohol (UNII: 2DMT128M1S) glycerin (UNII: PDC6A3C0OX) polysorbate 60 (UNII: CAL22UVI4M) dimethicone (UNII: 92RU3N3Y1O) methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q) C10-30 cholesterol/lanosterol esters (UNII: 137SL7IL0Y) cetyl ricinoleate (UNII: 1P677500YD) cetyl alcohol (UNII: 936JST6JCN) benzyl alcohol (UNII: LKG8494WBH) cetyl phosphate (UNII: VT07D6X67O) sodium metabisulfite (UNII: 4VON5FNS3C) trolamine Stearate (UNII: 1J6JM3JE61) phenoxyethanol (UNII: HIE492ZZ3T) magnesium aluminum silicate (UNII: 6M3P64V0NC) cyclomethicone 5 (UNII: 0THT5PCI0R) trolamine (UNII: 9O3K93S3TK) C13-14 isoparaffin (UNII: E4F12ROE70) PEG-10 soy sterol (UNII: FG54K98L0Q) cyclomethicone 6 (UNII: XHK3U310BA) edetate disodium (UNII: 7FLD91C86K) methylparaben (UNII: A2I8C7HI9T) retinol (UNII: G2SH0XKK91) polysorbate 20 (UNII: 7T1F30V5YH) Laureth-7 (UNII: Z95S6G8201) levomenol (UNII: 24WE03BX2T) ascorbic acid (UNII: PQ6CK8PD0R) .alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8) butylated hydroxytoluene (UNII: 1P9D0Z171K) ascorbyl palmitate (UNII: QN83US2B0N) propyl gallate (UNII: 8D4SNN7V92) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68634-051-01 1 in 1 CARTON 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 01/01/2015 Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803) Establishment Name Address ID/FEI Business Operations AMCOL Household & Personal Care 872684803 MANUFACTURE(68634-051) , PACK(68634-051) , LABEL(68634-051) , ANALYSIS(68634-051)
