Label: ZO MEDICAL ZO POST PROCEDURE RECOVERY SYSTEM- aluminum sulfate tetradecahydrate, calcium acetate monohydrate, and oatmeal

  • NDC Code(s): 42851-080-12, 42851-081-19, 42851-082-13
  • 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 May 1, 2015

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    POMATROL™ Soothing Ointment
    50 mL / 1.7 Fl. Oz.

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  • DIRECTIONS

    Use for the first four days post-procedure. After gently cleansing affected area and/or after applying Surfatrol™, an astringent solution compress, apply a thin coat of ointment and gently massage onto skin to protect and keep out airborne dirt and debris. This helps suppress dryness and scabbing. Applying too much ointment can cause premature skin peeling and increase the likelihood of post-procedure acne. Can also be used whenever skin feels dry or uncomfortable.

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  • CAUTION

    For external use only. Use only as directed. Keep out of eyes. If contact occurs, rinse thoroughly with cool water. Keep out of reach of children. If rash or other adverse reaction occurs, discontinue use and contact your doctor.

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  • INGREDIENTS

    Water (Aqua), Hydrogenated Polyisobutene, Caprylic/Capric/Myristic/Stearic Triglyceride, Glycerin, PEG-15/Lauryl Dimethicone Crosspolymer, Tribehenin, Helianthus Annuus Seed Oil, Beta-Glucan, Polyglyceryl-4 Isostearate, Polyglyceryl-4 Isostearate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Triethylhexanoin, Triethylhexanoin, Polymethyl Methacrylate, Phenoxyethanol, Magnesium Sulfate, Hexyl Laurate, Brassica Oleracea Italica Extract, Avena Sativa Kernel Flour, Panthenyl Triacetate, Ethyl Linoleate, Parfum, Ubiquinone, Erythritol, Chlorphenesin, C12-15 Alkyl Benzoate, Oleyl Alcohol, Sodium Hyaluronate, Tocopheryl Acetate, Butylene Glycol, Acetyl Tyrosine, Aminopropyl Dihydrogen Phosphate, Tocopherol, Proline, Retinyl Palmitate, Ascorbic Acid, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Disodium Acetyl Glucosamine Phosphate, Sodium Benzoate, Sodium Benzoate, Potassium Sorbate, Homarine HCL.

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  • SPL UNCLASSIFIED SECTION

    SURFATROL™ Astringent Solution Powder
    10 ea. Net Wt. 6 g / 0.21 Oz. (NDC 42851-081-19)

    Drug Facts

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  • ACTIVE INGREDIENT

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

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

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

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  • 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:

    • dip clean gauze in the solution
    • apply gauze loosely to affected area for 1 to 2 minutes
    • repeat 3-4 times a day as needed or as directed by a doctor
    • discard solution after each use
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  • Other information

    • Store at a comfortable temperature range indoors, usually considered to be 68 to 77°F (20 to 25°C).
    • Avoid storing at extreme temperatures above 104°F (40°C).
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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    REGENACELL™ Epidermal Repair Crème
    Skin Protectant
    2 ea. 120 mL / 4.0 Fl. Oz. (NDC 42851-080-12)

    Drug Facts

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  • Active ingredient

    Colloidal Oatmeal, 1%

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  • Purpose

    Skin Protectant

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  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes.
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  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
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  • Directions

    apply as needed

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  • Inactive ingredients

    Water, Isopropyl Isostearate, Glycerin, Petrolatum, Dimethicone, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Beta-Glucan, PEG-100 Stearate, Glyceryl Stearate, Steareth-21, Polymethyl Methacrylate, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzalkonium Chloride, Aminomethyl Propanol, Butylene Glycol, Myristoyl Pentapeptide-11, Tocopheryl Acetate, Tetrapeptide-21, Retinyl Palmitate, Ascorbic Acid.

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  • OTHER INFORMATION (STORAGE RECOMMENDATIONS)

    Store at controlled room temperature: 15-30°C (59-89°F), away from direct sunlight.

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  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc. Irvine, CA 92618

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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO®MEDICAL
    BY ZEIN OBAGI, MD

    NDC 42851-082-13

    ZO® POST PROCEDURE
    RECOVERY SYSTEM

    Principal Display Panel - Kit Carton
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  • INGREDIENTS AND APPEARANCE
    ZO MEDICAL  ZO POST PROCEDURE RECOVERY SYSTEM
    aluminum sulfate tetradecahydrate, calcium acetate monohydrate, and oatmeal kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-082
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42851-082-13 1 in 1 CARTON 11/14/2014
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 50 mL
    Part 2 1 PACKET 6 g
    Part 3 1 TUBE 120 mL
    Part 1 of 3
    ZO MEDICAL POMATROL 
    cleansing (cold creams, cleansing lotions, liquids, and pads) ointment
    Product Information
    Route of Administration TOPICAL
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    INGR SUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGR CURDLAN (UNII: 6930DL209R)  
    INGR POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    INGR CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    INGR TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    INGR POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    INGR PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGR MAGNESIUM SULFATE (UNII: DE08037SAB)  
    INGR HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    INGR OATMEAL (UNII: 8PI54V663Y)  
    INGR PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    INGR ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    INGR SULFURYL FLUORIDE (UNII: 64B59K7U6Q)  
    INGR UBIDECARENONE (UNII: EJ27X76M46)  
    INGR ERYTHRITOL (UNII: RA96B954X6)  
    INGR CHLORPHENESIN (UNII: I670DAL4SZ)  
    INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGR OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR N-ACETYLTYROSINE (UNII: DA8G610ZO5)  
    INGR AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
    INGR TOCOPHEROL (UNII: R0ZB2556P8)  
    INGR PROLINE (UNII: 9DLQ4CIU6V)  
    INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGR ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGR ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    INGR SODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGR HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 50 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 11/14/2014
    Part 2 of 3
    ZO MEDICAL SURFATROL 
    aluminum sulfate tetradecahydrate and calcium acetate monohydrate powder
    Product Information
    Item Code (Source) NDC:42851-081
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE 4866 mg  in 4.866 g
    Inactive Ingredients
    Ingredient Name Strength
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    WHEY (UNII: 8617Z5FMF6)  
    SHRIMP SHELL CHITIN (UNII: 8SH93A7QWW)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42851-081-19 6 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 11/14/2014
    Part 3 of 3
    ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT 
    oatmeal lotion
    Product Information
    Item Code (Source) NDC:42851-080
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SHEANUT OIL (UNII: O88E196QRF)  
    CURDLAN (UNII: 6930DL209R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARETH-21 (UNII: 53J3F32P58)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42851-080-12 120 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
    OTC MONOGRAPH FINAL part347 11/14/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 11/14/2014
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    Name Address ID/FEI Business Operations
    PakLab 790530976 MANUFACTURE(42851-082)
    Establishment
    Name Address ID/FEI Business Operations
    Colonial Enterprises, Inc. 800856333 MANUFACTURE(42851-082)
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