NDC | 42851-030-32, 42851-031-32, 42851-052-60, 42851-131-98 |
Set ID | 3f9bd7a0-3aa1-484d-a72a-e75d4f81f7e7 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- MELAMIN™ Skin Bleaching & Correcting Crème
- DOSAGE AND ADMINISTRATION
-
WARNINGS
Keep out of reach of children. Contains sodium metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.
- SUNBURN ALERT
- STORAGE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- MELAMIX™ Skin Lightener & Blending Crème
-
DOSAGE AND ADMINISTRATION
Combine 1g tretinoin with 1 pump Melamix™ at night to affected areas or as directed by a physician, directly following Melamin™ for a gradual bleaching of hyperpigmented skin conditions. (See enclosed package insert for full prescribing information.)
Mild Start 1-2×/week, increasing as tolerated. Moderate Use every other day, increasing as tolerated. Aggressive Use every AM and PM as tolerated. Always use sunscreen protection. -
WARNINGS
Keep out of reach of children. Contains sodium metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a poison control center right away.
- SUNBURN ALERT
- STORAGE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- OCLIPSE-C™ Broad-Spectrum Sunscreen SPF 50
- Active ingredient
- Purpose
-
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
- Other information
-
Directions
- For full protection, apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- For children under 6 months of age: ask a doctor.
-
Sun Protection Measures. Spending time in the sun increases your risk off skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
- -
- Limit time in the sun, especially from 10 a.m.- 2 p.m.
- -
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Apply to all skin exposed to the sun.
-
Inactive ingredients
Water (Aqua), Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja Extract, Silica, C13-14 Isoparaffin, Laureth-7.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM
hydroquinone and titanium dioxide kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42851-131 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-131-98 1 in 1 CARTON 03/01/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 32 g Part 2 1 BOTTLE, PLASTIC 32 g Part 3 1 TUBE 60 g Part 4 1 BOTTLE, PLASTIC 30 mL Part 5 1 BOTTLE, PUMP 30 mL Part 1 of 5 MELAMIN SKIN BLEACHING AND CORRECTING
hydroquinone creamProduct Information Item Code (Source) NDC:42851-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ascorbic Acid (UNII: PQ6CK8PD0R) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Cetyl Alcohol (UNII: 936JST6JCN) Edetate Disodium (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Glycolic Acid (UNII: 0WT12SX38S) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Water (UNII: 059QF0KO0R) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Metabisulfite (UNII: 4VON5FNS3C) Stearyl Alcohol (UNII: 2KR89I4H1Y) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-030-32 32 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2012 Part 2 of 5 MELAMIX SKIN LIGHTENER AND BLENDING
hydroquinone creamProduct Information Item Code (Source) NDC:42851-031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength Ascorbic Acid (UNII: PQ6CK8PD0R) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Cetyl Alcohol (UNII: 936JST6JCN) Edetate Disodium (UNII: 7FLD91C86K) Ethylhexyl Palmitate (UNII: 2865993309) Glycerin (UNII: PDC6A3C0OX) Glycolic Acid (UNII: 0WT12SX38S) Methylparaben (UNII: A2I8C7HI9T) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Propylparaben (UNII: Z8IX2SC1OH) Water (UNII: 059QF0KO0R) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Metabisulfite (UNII: 4VON5FNS3C) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-031-32 32 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2012 Part 3 of 5 ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50
titanium dioxide lotionProduct Information Item Code (Source) NDC:42851-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.08 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) EDETATE DISODIUM (UNII: 7FLD91C86K) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) LAURYL LACTATE (UNII: G5SU0BFK7O) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) MELAMINE (UNII: N3GP2YSD88) ERYTHRITOL (UNII: RA96B954X6) HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) NEPHELIUM LAPPACEUM FRUIT RIND (UNII: Y0513T90FO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-052-60 60 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 06/01/2013 Part 4 of 5 ZO MEDICAL GLYCOGENT EXFOLIATION ACCELERATOR CONCENTRATION
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCOLIC ACID (UNII: 0WT12SX38S) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR SQUALANE (UNII: GW89575KF9) INGR PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0) INGR STEAPYRIUM CHLORIDE (UNII: C9842BS3SX) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR SAFFLOWER OIL (UNII: 65UEH262IS) INGR ALLANTOIN (UNII: 344S277G0Z) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SODIUM CARBONATE (UNII: 45P3261C7T) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/01/2012 Part 5 of 5 OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR CETEARYL ISONONANOATE (UNII: P5O01U99NI) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR RETINOL (UNII: G2SH0XKK91) INGR EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR JOJOBA BUTTER (UNII: XIA46H803R) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR CURDLAN (UNII: 6930DL209R) INGR LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) INGR ORANGE OIL (UNII: AKN3KSD11B) INGR MANDARIN OIL (UNII: NJO720F72R) INGR LEMON OIL (UNII: I9GRO824LL) INGR PEPPERMINT OIL (UNII: AV092KU4JH) INGR MIMOSA TENUIFLORA BARK (UNII: 515MQE449I) INGR ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) INGR C14-22 ALCOHOLS (UNII: B1K89384RJ) INGR CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) INGR C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) INGR PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) INGR HYPROMELLOSES (UNII: 3NXW29V3WO) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR LIMONENE, (+/-)- (UNII: 9MC3I34447) INGR ULTRAMARINE BLUE (UNII: I39WR998BI) INGR EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/11/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 03/01/2014 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Sanitor Corporation 797472792 MANUFACTURE(42851-131) Establishment Name Address ID/FEI Business Operations PhytogenX, Inc. 624386772 MANUFACTURE(42851-131) Establishment Name Address ID/FEI Business Operations PAKLAB 790530976 MANUFACTURE(42851-131)