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| Product NDC Code | 69473-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Alumier md hydrasmooth non-comedogenic moisturizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 417424 | ||||
| Application Number | M006 | ||||
| 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 Ingredient Salicylic Acid 1.0%
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 for adults 18 years and older cleanse skin thoroughly before applying the product For New Users apply product to a small area once a day for three days to test if you are sensitive to this product if no discomfort occurs, cover the entire affected area with a thin layer start with one application daily, then gradually increase to two to three times daily, if needed if dryness or peeling occurs, reduce application to once a day or every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, Propanediol, Caprylyl Methicone, Dimethicone, Caprylic/Capric Triglyceride, Butylene Glycol, Glycerin, Cetearyl Alcohol, Cocamidopropyl Dimethylamine, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glyceryl Stearate, Sucrose Stearate, Aloe Barbadensis Leaf Juice, Hinokitiol, Poria Cocos Extract, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa Bran Extract, Resveratrol, Allantoin, Oligopeptide-10, Spiraea Ulmaria Extract, Tocopheryl Acetate, Sodium Hyaluronate, Polysilicone-11, Polymethyl Methacrylate, Adipic Acid/Diglycol Crosspolymer, Tricaprylin, Caprylyl Glycol, Xanthan Gum, Caprylic Acid, Sorbitan Stearate, Sodium Hydroxide, Disodium EDTA, Tocopherol, Xylitol, Citric Acid, 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 for the treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.Alumier MD HydraSmooth Non-Comedogenic Moisturizer Salicylic Acid DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CETOSTEARYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POTASSIUM CETYL PHOSPHATE ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) CAPRYLIC ACID ALOE VERA LEAF CAPRYLYL TRISILOXANE PROPANEDIOL SUCROSE STEARATE FU LING WATER ALPHA-TOCOPHEROL ACETATE ALLANTOIN BUTYLENE GLYCOL COCAMIDOPROPYL DIMETHYLAMINE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER POLY(METHYL METHACRYLATE; 450000 MW) CAPRYLYL GLYCOL EDETATE DISODIUM EDETIC ACID GLYCERIN INDIAN FRANKINCENSE RESVERATROL XANTHAN GUM HONEY DIMETHICONE GLYCERYL MONOSTEARATE .BETA.-THUJAPLICIN RICE BRAN OLIGOPEPTIDE-10 FILIPENDULA ULMARIA WHOLE HYALURONATE SODIUM SORBITAN MONOSTEARATE CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN SALICYLIC ACID SALICYLIC ACID TRICAPRYLIN SODIUM HYDROXIDE XYLITOL TOCOPHEROL
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
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
Company Information ALUMIER EUROPE LTD. VISION EXCHANGE BUILDING TERRITORIALS STREET ZONE 1, CENTRAL BUSINESS DISTRICT BIRKIRKARA CBD 1070, MALTA WWW.ALUMIERMD.COM DISTRIBUTED IN CANADA BY ALUMIER LABS INC., 436 LIMESTONE CRESCENT TORONTO, ON, M3J 2S4 DISTRIBUTED IN THE USA BY ALUMIER LABS INC., 550 COCHITUATE ROAD, SUITE 25 FRAMINGHAM, MA 01701 MANUFACTURED IN CANADA UNDER LICENSE FROM ALUMIER EUROPE LTD.
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 is broken or missing You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 550 Cochituate Road, Suite 25, 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 you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing. for more severe cases, and/or if improvement is not apparent within 6-8 weeks
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. skin irritation and dryness is more likely to occur if you use another topical acne product at the same time. If irritation occurs, only use one topical acne product at a time.
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. skin irritation and dryness is more likely to occur if you use another topical acne product at the same time. If irritation occurs, only use one topical acne product at a time. Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing. for more severe cases, and/or if improvement is not apparent within 6-8 weeks 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