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| Product NDC Code | 42851-193 | ||||
|---|---|---|---|---|---|
| Drug Name | Zo skin health post procedure recovery system |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M016 | ||||
| Labeler Name | ZO Skin Health, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Aluminum Sulfate Tetradecahydrate, 2850 mg Astringent When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions Calcium Acetate Monohydrate, 2016 mg Astringent
| Aluminum Sulfate Tetradecahydrate, 2850 mg | Astringent |
| Calcium Acetate Monohydrate, 2016 mg | Astringent |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein, Potassium Sorbate, Chitosan.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.
Purpose
Information about the drug product’s indications for use.Active Ingredient Purpose Aluminum Sulfate Tetradecahydrate, 2850 mg Astringent When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions Calcium Acetate Monohydrate, 2016 mg Astringent
| Aluminum Sulfate Tetradecahydrate, 2850 mg | Astringent |
| Calcium Acetate Monohydrate, 2016 mg | Astringent |
Spl product data elements
Usually a list of ingredients in a drug product.ZO Skin Health Post Procedure Recovery System Aluminum Acetate ZO Skin Health Pomatrol Soothing ZO Skin Health Pomatrol Soothing WATER HYDROGENATED POLYBUTENE (1300 MW) GLYCERIN TRIBEHENIN SUNFLOWER OIL POLYGLYCERYL-4 ISOSTEARATE TRIETHYLHEXANOIN POLY(METHYL METHACRYLATE; 450000 MW) PHENOXYETHANOL MAGNESIUM SULFATE, UNSPECIFIED FORM HEXYL LAURATE BROCCOLI OATMEAL PANTHENOL TRIACETATE, (+)- ETHYL LINOLEATE ERYTHRITOL CHLORPHENESIN ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE OLEYL ALCOHOL BUTYLENE GLYCOL N-ACETYLTYROSINE AMINOPROPYL DIHYDROGEN PHOSPHATE PROLINE UBIDECARENONE VITAMIN A PALMITATE ASCORBIC ACID TOCOPHEROL ADENOSINE TRIPHOSPHATE DISODIUM ACETYL GLUCOSAMINE PHOSPHATE HYALURONATE SODIUM SODIUM BENZOATE POTASSIUM SORBATE POLYOXYL 35 CASTOR OIL PEG-12 GLYCERYL LAURATE HOMARINE HYDROCHLORIDE POVIDONE, UNSPECIFIED EDETATE DISODIUM ANHYDROUS ZO Skin Health Hydrating Creme ZO Skin Health Hydrating Creme WATER GLYCERIN PETROLATUM DISTEARYLDIMONIUM CHLORIDE ISOPROPYL PALMITATE CYCLOMETHICONE 5 CETYL ALCOHOL SHEA BUTTER OATMEAL OPHIOPOGON JAPONICUS ROOT .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE ASCORBIC ACID TETRAPEPTIDE-21 MYRISTOYL PENTAPEPTIDE-4 POLY(METHYL METHACRYLATE; 450000 MW) GLYCYRRHIZINATE DIPOTASSIUM MALTODEXTRIN BENZALKONIUM CHLORIDE BUTYLENE GLYCOL SODIUM CHLORIDE BENZYL ALCOHOL ZO Skin Health Surfatrol Astringent Solution Aluminum Acetate WATER OAT SOY PROTEIN WHEY POTASSIUM SORBATE ALUMINUM ACETATE ALUMINUM CATION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Storage and handling
Information about safe storage and handling of the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API