Label: ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM- aluminum acetate kit

  • NDC Code(s): 42851-088-06, 42851-193-06
  • Packager: ZO Skin Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    *
    When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions
    Aluminum Sulfate Tetradecahydrate, 2850 mgAstringent *
    Calcium Acetate Monohydrate, 2016 mgAstringent *
  • Uses

    • For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • do not cover compress or wet dressing with plastic to prevent evaporation
    • in some skin conditions, soaking too long may overdry

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • dissolve 1 packet in 12 oz. of cool or warm water.
    • stir until fully dissolved; do not strain or filter.

    The resulting mixture contains 0.45% aluminum acetate and is ready for use.

    For use as a compress or wet dressing:

    • soak a clean, soft cloth in the solution
    • apply cloth loosely to affected area for 15 to 30 minutes
    • repeat as needed or as directed by a doctor
    • discard solution after each use
  • Inactive Ingredients

    Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein, Potassium Sorbate, Chitosan.

  • Other Information

    • Store at controlled room temperature: 15-30°C (59-86°F), away from direct sunlight.
    • You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618
  • SPL UNCLASSIFIED SECTION

    Dist. by ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO ®SKIN HEALTH
    BY ZEIN OBAGI MD

    POST PROCEDURE RECOVERY SYSTEM

    NDC 42851-193-06

    POMATROL ®Soothing Ointment 50 mL / 1.7 Fl. Oz.
    HYDRATING CRÈME Net Wt.113 g / 4 Oz.
    SURFATROL ®Astringent Solution Powder 10 ea. Net Wt.6 g / 0.21 Oz.

    US Patent No. 9,248,160

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM 
    aluminum acetate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-193
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-193-061 in 1 CARTON01/31/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 50 mL
    Part 21 TUBE 113 g
    Part 31 PACKET 6 g
    Part 1 of 3
    ZO SKIN HEALTH POMATROL SOOTHING 
    cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] ointment
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRHYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRTRIBEHENIN (UNII: 8OC9U7TQZ0)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRPOLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    INGRTRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    INGRPOLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRMAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    INGRHEXYL LAURATE (UNII: 4CG9F9W01Q)  
    INGRBROCCOLI (UNII: UOI4FT57BZ)  
    INGROATMEAL (UNII: 8PI54V663Y)  
    INGRPANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    INGRETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    INGRERYTHRITOL (UNII: RA96B954X6)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGROLEYL ALCOHOL (UNII: 172F2WN8DV)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRN-ACETYLTYROSINE (UNII: DA8G610ZO5)  
    INGRAMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
    INGRPROLINE (UNII: 9DLQ4CIU6V)  
    INGRUBIDECARENONE (UNII: EJ27X76M46)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    INGRDISODIUM ACETYL GLUCOSAMINE PHOSPHATE (UNII: SC89MF712W)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRPOLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    INGRPEG-12 GLYCERYL LAURATE (UNII: J07WW42G15)  
    INGRHOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    INGRPOVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/31/2019
    Part 2 of 3
    ZO SKIN HEALTH HYDRATING CREME 
    body and hand (excluding shaving preparations), rinse-off [skin care preparations (creams, lotions, powder, and sprays)] lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPETROLATUM (UNII: 4T6H12BN9U)  
    INGRDISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGROATMEAL (UNII: 8PI54V663Y)  
    INGROPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGRTETRAPEPTIDE-21 (UNII: 179JUC43HU)  
    INGRMYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    INGRPOLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRBENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/31/2019
    Part 3 of 3
    ZO SKIN HEALTH SURFATROL ASTRINGENT SOLUTION 
    aluminum acetate powder
    Product Information
    Item Code (Source)NDC:42851-088
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE4866 mg  in 6 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OAT (UNII: Z6J799EAJK)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    WHEY (UNII: 8617Z5FMF6)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-088-066 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/31/2019
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(42851-193)
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