- Gentle Cleanser 6.7 fl. oz. (198 mL)
-
Ingredients
water (aqua), cocamidopropyl betaine, glycerin, aloe barbadensis leaf juice, sodium lauroyl oat amino acids, sodium laureth sulfate, sodium chloride, glycereth-7, prunus armeniaca (apricot) kernel oil, borago officinalis extract, salvia officinalis (sage) leaf extract, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, oleyl lactate, saponins, citric acid, tetrasodium EDTA, triethanolamine, ethoxydiglycol, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), Yellow 5 (CI 19140)
- Metronidazole Topical Gel USP, 0.75% NDC 62032-123-65 Net wt. 45 g
- Each gram contains
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- Hydrating Complexion Corrector Net wt. 3 oz. (85 g)
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Ingredients
water (aqua), titanium dioxide (CI 77891), isohexadecane, coco-caprylate/caprate, ethylhexyl palmitate, dipropylene glycol, PEG-6, propylene glycol, stearyl alcohol, isocetyl behenate, glyceryl stearate, PEG-100 stearate, glycerin, talc, dimethicone, C13-15 alkane, allantoin, aloe barbadensis leaf juice, bacopa monniera extract, hydrolyzed oat protein, avena sativa (oat) beta glucan, avena sativa (oat) kernel extract, sodium cocoyl amino acids, arnica montana flower extract, cupressus sempervirens seed extract, polygonatum multiflorum rhizome/root extract, glycyrrhiza glabra (licorice) root extract, lavandula angustifolia (lavender) flower/leaf/stem extract, sea whip extract (gorgonia extract), tocopheryl acetate, butylene glycol, ethylhexyl stearate, bisabolol, cetyl alcohol, polysorbate 60, sarcosine, pentylene glycol, hydroxyethylcellulose, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, magnesium aluminum silicate, xanthan gum, magnesium aspartate, potassium aspartate, potassium sorbate, diazolidinyl urea, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, alumina, silica, mica, iron oxides (CI 77491, CI 77492, CI 77499)
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
ROSACLEAR SYSTEM
metronidazole kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-507 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-507-65 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 198 mL Part 2 1 TUBE 85 g Part 3 1 TUBE 45 g Part 1 of 3 ROSACLEAR SYSTEM GENTLE CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR APRICOT KERNEL OIL (UNII: 54JB35T06A) INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAURETH SULFATE (UNII: BPV390UAP0) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR GLYCERETH-7 (UNII: 3D2Y91QZ2H) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR SAGE (UNII: 065C5D077J) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR OLEYL LACTATE (UNII: B3AWW0N3GM) INGR CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 198 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2009 Part 2 of 3 ROSACLEAR SYSTEM HYDRATING COMPLEXION CORRECTOR
face and neck (excluding shaving preparations) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR WATER (UNII: 059QF0KO0R) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) INGR POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) INGR TALC (UNII: 7SEV7J4R1U) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR ALUMINUM OXIDE (UNII: LMI26O6933) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR ISOHEXADECANE (UNII: 918X1OUF1E) INGR MICA (UNII: V8A1AW0880) INGR FERRIC OXIDE RED (UNII: 1K09F3G675) INGR FERROSOFERRIC OXIDE (UNII: XM0M87F357) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR FERRIC OXIDE YELLOW (UNII: EX438O2MRT) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) INGR TITANIUM DIOXIDE (UNII: 15FIX9V2JP) INGR COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INGR CUPRESSUS SEMPERVIRENS SEED (UNII: V5M93EG3SN) INGR POLYGONATUM MULTIFLORUM ROOT (UNII: EYW899536C) INGR SARCOSINE (UNII: Z711V88R5F) INGR POTASSIUM ASPARTATE (UNII: OC4598NZEQ) INGR MAGNESIUM ASPARTATE (UNII: R17X820ROL) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR ISOCETYL BEHENATE (UNII: JGD5498E0G) INGR STEARYL ALCOHOL (UNII: 2KR89I4H1Y) INGR C13-15 ALKANE (UNII: 114P5I43UJ) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) INGR ALLANTOIN (UNII: 344S277G0Z) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR OAT (UNII: Z6J799EAJK) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) INGR GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2009 Part 3 of 3 METRONIDAZOLE
metronidazole gelProduct Information Item Code (Source) NDC:62032-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E) METRONIDAZOLE 7.5 mg in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-123-65 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077547 12/29/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/29/2012 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Business Operations TOLMAR PHARMACEUTICALS 791156578 MANUFACTURE(62032-507) Establishment Name Address ID/FEI Business Operations Swiss-American Products 611921669 MANUFACTURE(62032-507)