Label: ZO SKIN HEALTH SKIN NORMALIZING SYSTEM WITH ROZATROL BOOSTER SERUM- salicylic acid kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 42851-186-60 - Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
-
Directions
- Clean the skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Other Information
-
Inactive Ingredients
Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH SKIN NORMALIZING SYSTEM WITH ROZATROL BOOSTER SERUM
salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-186 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-186-60 1 in 1 CARTON 05/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 9 mL Part 2 1 TUBE 60 mL Part 3 1 JAR 16.2 g Part 4 60 PATCH 48 mL Part 5 1 BOTTLE 30 mL Part 6 1 TUBE 20 mL Part 1 of 6 ZO SKIN HEALTH HYDRAFACIAL ROZATROL BOOSTER SERUM
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR LACTOSE (UNII: J2B2A4N98G) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR ROSA CANINA FRUIT (UNII: 3TNW8D08V3) INGR CASEIN (UNII: 48268V50D5) INGR PAPAIN (UNII: A236A06Y32) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR BETASIZOFIRAN (UNII: 2X51AD1X3T) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR SODIUM ALGINATE (UNII: C269C4G2ZQ) INGR PALMITOYL GLYCINE (UNII: M6V3RIU5KI) INGR PEG-12 GLYCERYL LAURATE (UNII: J07WW42G15) INGR POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) INGR PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) INGR SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) INGR FARNESOL (UNII: EB41QIU6JL) INGR FARNESYL ACETATE (UNII: 2ARF3ZNJ1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/01/2018 Part 2 of 6 ZO SKIN HEALTH GENTLE CLEANSER
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 SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P) INGR PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) INGR BARLEY (UNII: 5PWM7YLI7R) INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0) INGR PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8) INGR CRITHMUM MARITIMUM (UNII: J7IHY79BKY) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/01/2018 Part 3 of 6 ZO SKIN HEALTH EXFOLIATING POLISH
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) INGR SODIUM BICARBONATE (UNII: 8MDF5V39QO) INGR MAGNESIUM OXIDE (UNII: 3A3U0GI71G) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR OLETH-20 (UNII: YTH167I2AG) INGR TRIHYDROXYSTEARIN (UNII: 06YD7896S3) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR MINERAL OIL (UNII: T5L8T28FGP) INGR WATER (UNII: 059QF0KO0R) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR TEA TREE OIL (UNII: VIF565UC2G) INGR SOY STEROL (UNII: PL360EPO9J) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) INGR TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR D&C GREEN NO. 6 (UNII: 4QP5U84YF7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16.2 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/01/2018 Part 4 of 6 ZO SKIN HEALTH OIL CONTROL PADS, ACNE TREATMENT
salicylic acid patchProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CRITHMUM MARITIMUM (UNII: J7IHY79BKY) GLYCOLIC ACID (UNII: 0WT12SX38S) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) BARLEY (UNII: 5PWM7YLI7R) MANDELIC ACID (UNII: NH496X0UJX) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) PHENOXYETHANOL (UNII: HIE492ZZ3T) PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8) PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P) ROSA CANINA FRUIT (UNII: 3TNW8D08V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 in 1 JAR 1 0.8 mL in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/01/2018 Part 5 of 6 ZO SKIN HEALTH DAILY POWER DEFENSE
lotions, oils, powders, and creams 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 GLYCERIN (UNII: PDC6A3C0OX) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR C14-22 ALCOHOLS (UNII: B1K89384RJ) INGR CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) INGR SAFFLOWER OIL (UNII: 65UEH262IS) INGR C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) INGR POWDERED CELLULOSE (UNII: SMD1X3XO9M) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR RETINOL (UNII: G2SH0XKK91) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) INGR ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) 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 TANGERINE (UNII: KH3E3096OO) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR FARNESOL (UNII: EB41QIU6JL) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) INGR PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) 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; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/01/2018 Part 6 of 6 ZO SKIN HEALTH ROZATROL TREATMENT FOR RED, SENSITIZED SKIN
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR PALMITOYL GLYCINE (UNII: M6V3RIU5KI) INGR NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) INGR LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) INGR CASEIN (UNII: 48268V50D5) INGR NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW) INGR PAPAIN (UNII: A236A06Y32) INGR MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) INGR PEG-12 GLYCERYL LAURATE (UNII: J07WW42G15) INGR POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) INGR PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B) INGR FARNESOL (UNII: EB41QIU6JL) INGR FARNESYL ACETATE (UNII: 2ARF3ZNJ1R) INGR AMINOMETHYLPROPANOL (UNII: LU49E6626Q) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR SODIUM ALGINATE (UNII: C269C4G2ZQ) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) INGR CHLORPHENESIN (UNII: I670DAL4SZ) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 20 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/01/2018 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC 081239587 manufacture(42851-186) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 manufacture(42851-186) Establishment Name Address ID/FEI Business Operations PakLab 790530976 manufacture(42851-186)
