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| Product NDC Code | 70604-040 | ||||
|---|---|---|---|---|---|
| Drug Name | Procedure enhancement system |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M020 | ||||
| Labeler Name | Alastin Skincare, Inc. | ||||
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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 Ingredients Zinc Oxide 19.95%
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 Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every two hours Children under 6 months of age: Ask a doctor. Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm Wear long-sleeved shirts, pants, hats and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Dimethicone, Cyclopentasiloxane, Polysilicone-11, Squalane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Palmitoyl Hexapeptide-12, Palmitoyl Tripeptide-1, Dunaliella Salina Extract, Ectoin, Hydroxymethoxyphenyl Decanone, Tocopherol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Disteardimonium Hectorite, Pentaerythrityl Tetraisostearate, Propylene Carbonate
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 Helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Procedure Enhancement System ZINC OXIDE Ultra Calm Cleansing WATER MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL GLYCERIN CETEARYL METHICONE (15000 MW) DIMETHICONE GLYCERYL MONOSTEARATE POLYOXYL 20 CETOSTEARYL ETHER POLYACRYLATE-13 PHENOXYETHANOL POLYISOBUTYLENE (1000 MW) POTASSIUM HYDROLYZED JOJOBA ESTERS PANTHENOL CAPRYLYL GLYCOL SOY STEROL LINOLEIC ACID LECITHIN, SOYBEAN XANTHAN GUM GLYCERYL MONOOLEATE STEARYL GLYCYRRHETINATE EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN BETAINE CAPRYLHYDROXAMIC ACID POLYSORBATE 20 SORBITAN ISOSTEARATE POTASSIUM SORBATE SODIUM BENZOATE BENZYL ALCOHOL TREMELLA FUCIFORMIS FRUITING BODY ANHYDROUS CITRIC ACID .GAMMA.-TOCOPHEROL Regenerating Skin Nectar CYCLOMETHICONE 5 DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) PENTAERYTHRITYL TETRAISOSTEARATE HEPTYL UNDECYLENATE SOYBEAN OIL PANTHENOL TRIACETATE, (+)- SQUALANE CAPRYLYL TRISILOXANE MEDIUM-CHAIN TRIGLYCERIDES NARINGENIN OLIVE OIL LECITHIN, SOYBEAN PROPYLENE CARBONATE STEARALKONIUM HECTORITE ARNICA MONTANA FLOWER DUNALIELLA SALINA .GAMMA.-TOCOPHEROL PALMITOYL HEXAPEPTIDE-12 PALMITOYL TRIPEPTIDE-1 ASCORBYL PALMITATE Ultra Light Moisturizer WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN CETOSTEARYL ALCOHOL DIMETHICONE GLYCERYL MONOSTEARATE POLYOXYL 20 CETOSTEARYL ETHER POLYACRYLATE-13 PHENOXYETHANOL SQUALANE POLYISOBUTYLENE (1000 MW) POTASSIUM HYDROLYZED JOJOBA ESTERS PANTHENOL CAPRYLYL GLYCOL XANTHAN GUM GLYCERYL MONOOLEATE STEARYL GLYCYRRHETINATE CERAMIDE NP GREEN TEA LEAF EDETATE DISODIUM ANHYDROUS .ALPHA.-BISABOLOL, (+/-)- BETAINE ETHYLHEXYLGLYCERIN CAPRYLHYDROXAMIC ACID POLYGLYCERYL-10 STEARATE POLYSORBATE 20 SORBITAN ISOSTEARATE SUCROSE STEARATE POTASSIUM SORBATE SODIUM BENZOATE SilkShield All Mineral Sunscreen with TriHex Technology ZINC OXIDE ZINC OXIDE ZINC OXIDE DIMETHICONE CYCLOMETHICONE 5 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SQUALANE POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE PALMITOYL HEXAPEPTIDE-12 PALMITOYL TRIPEPTIDE-1 DUNALIELLA SALINA ECTOINE 1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES STEARALKONIUM HECTORITE DISTEARDIMONIUM HECTORITE PENTAERYTHRITYL TETRAISOSTEARATE PROPYLENE CARBONATE
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 074A ALASTIN ® SKINCARE PROCEDURE ENHANCEMENT SYSTEM with TriHex Technology ® Expertly formulated to complement in-office cosmetic treatments by enhancing results and accelerating recovery. Ideal for sensitive and post-procedure skin. 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
Distributed by Alastin Skincare ® , Inc., a Galderma Company Carlsbad, CA 92010
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect the product in this container from excessive heat and direct sun. Store at room temperature 15° - 30°C (59° - 86°F).
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. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is 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