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| Product NDC Code | 69473-019 | ||||
|---|---|---|---|---|---|
| Drug Name | Alumier md post procedure kit |
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| Type | Brand | ||||
| Route | TOPICAL | ||||
| Dosage Form | KIT | ||||
| Application Number | M020 | ||||
| Labeler Name | Alumier Labs | ||||
| 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 Ingredients Titanium Dioxide 7% Zinc Oxide 6.18%
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/generously (and evenly) 15 minutes before sun exposure reapply at least every 2 hours 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 10 a.m. - 2 p.m. - wear long-sleeved shirts, pants, hats and sunglasses use a water resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Non-medicinal ingredients Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Niacinamide, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Caprylyl Methicone, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, PEG-100 Stearate, Vitis Vinifera Seed Extract, Sodium Hyaluronate, Resveratrol, Lecithin, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Glutathione, Acacia Senegal Gum, Cellulose Gum, Microcrystalline Cellulose, Polysilicone-11, Triethoxycaprylylsilane, Ceteareth-20, Polyhydroxystearic Acid, Xanthan Gum, Disodium EDTA, Alumina, Tocopherol, Alteromonas Ferment Extract, Butylene Glycol, Physalis Angulata Extract, Polygonum Aviculare Extract, Xylitol, Caprylic Acid, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin.
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.Use 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.Alumier MD Post Procedure Kit Titanium Dioxide, Zinc Oxide Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen Titanium Dioxide, Zinc Oxide XYLITOL CAPRYLIC ACID ETHYLHEXYLGLYCERIN HYALURONATE SODIUM LECITHIN, SUNFLOWER POLYHYDROXYSTEARIC ACID (2300 MW) BUTYLENE GLYCOL TRICAPRYLIN NIACINAMIDE CAPRYLYL METHICONE POLYGONUM AVICULARE TOP ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE TRIETHOXYCAPRYLYLSILANE WATER GLYCERYL MONOSTEARATE ACACIA POLYOXYL 20 CETOSTEARYL ETHER MAGNESIUM ASCORBYL PHOSPHATE ASCORBIC ACID BUTYLOCTYL SALICYLATE GLYCERIN VITIS VINIFERA SEED ALUMINUM MONOSTEARATE MEDIUM-CHAIN TRIGLYCERIDES XANTHAN GUM ALKYL (C12-15) BENZOATE PROPANEDIOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL ACETATE MICROCRYSTALLINE CELLULOSE EDETATE DISODIUM EDETIC ACID CETOSTEARYL ALCOHOL PEG-100 STEARATE ALUMINUM OXIDE GLUTATHIONE PHENOXYETHANOL RESVERATROL TOCOPHEROL PHYSALIS ANGULATA POLY(METHYL METHACRYLATE; 450000 MW) SODIUM BENZOATE DIMETHICONE CAPRYLYL GLYCOL PENTYLENE GLYCOL POTASSIUM SORBATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) Alumier MD SensiCalm Gentle Facial Cleanser SODIUM COCOYL GLUTAMATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL NIACINAMIDE ALLANTOIN .ALPHA.-TOCOPHEROL ACETATE P-ANISIC ACID XANTHAN GUM SODIUM HYDROXIDE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE XYLITOL CAPRYLIC ACID 4-TERPINEOL, (+/-)- EDETATE SODIUM EDETIC ACID EDETATE DISODIUM EDETIC ACID COCAMIDOPROPYL HYDROXYSULTAINE WATER GLYCERIN PROPANEDIOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) ALOE VERA LEAF YUCCA SCHIDIGERA ROOT SUNFLOWER OIL LINALYL ACETATE .BETA.-OCIMENE, (3Z)- SODIUM CHLORIDE DISODIUM COCOYL GLUTAMATE CAPRYLYL GLYCOL LINALOOL, (+/-)- SORBITAN MONOOLEATE CERAMIDE NG SUCROSE STEARATE POLYISOBUTYLENE (1000 MW) CITRIC ACID MONOHYDRATE Alumier MD Rescue Balm Pro Post Procedure Facial Moisturizer HYDROGENATED OLIVE OIL UNSAPONIFIABLES FU LING LECITHIN, SUNFLOWER WATER GLYCERIN DIMETHICONE DOCOSANOL COCOA BUTTER NIACINAMIDE PREZATIDE COPPER INDIAN FRANKINCENSE HONEY EDETATE DISODIUM EDETIC ACID TRICAPRYLIN XYLITOL SODIUM METHYL STEAROYL TAURATE XANTHAN GUM ETHYLHEXYLGLYCERIN MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL SHEA BUTTER JOJOBA OIL RESVERATROL ASPALATHUS LINEARIS LEAF SQUALANE ALOE VERA LEAF POLY(METHYL METHACRYLATE; 450000 MW) SODIUM HYDROXIDE CAPRYLYL GLYCOL CAPRYLIC ACID HYDROGENATED SOYBEAN LECITHIN CITRIC ACID MONOHYDRATE CERAMIDE NP CERAMIDE NG
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.Product Packaging 1 1 1 1 1 1
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.Product Facts - Clear Shield
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on broken skin
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, call a Poison Control Centre or get medical help right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store in a cool, dry place at room temperature. Do not use if security seal on box is broken or missing. You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701
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 rash occurs
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.
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 Do not use on broken skin When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs Keep out of reach of children If swallowed, call a Poison Control Centre or get medical help 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