NDC | 42851-080-12, 42851-081-19, 42851-082-13 |
Set ID | 6450e110-c61f-4a50-aafa-df5c6427c351 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- SPL UNCLASSIFIED SECTION
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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.
- CAUTION
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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.
- SPL UNCLASSIFIED SECTION
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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* - Uses
- Warnings
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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
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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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.
- OTHER INFORMATION (STORAGE RECOMMENDATIONS)
- SPL UNCLASSIFIED SECTION
- 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 kitProduct 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) ointmentProduct 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 powderProduct 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 lotionProduct 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)