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| Product NDC Code | 69473-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Alumier md acne balancing serum |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 317152 | ||||
| Application Number | part333D | ||||
| 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 2.0%
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 cleanse skin thoroughly before applying the product cover the entire affected area with a thin layer one to three times daily or as directed by a health care practitioner if dryness or peeling occurs, reduce application to once a day or every other day 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, Dimethyl Isosorbide, Propanediol, Niacinamide, Glyceryl Caprate, Hinokitiol, Sea Whip Extract, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Gum Extract, Aloe Barbadensis Leaf Juice, Caprylic Acid, Caprylyl Glycol, Sodium Hyaluronate, Glycerin, Resveratrol, Oligopeptide-10, Honey Extract (Extrait de Miel), Allantoin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allyl Methacrylates Crosspolymer, Xanthan Gum, Cetyl Hydroxyethylcellulose, Pentylene Glycol, Disodium EDTA, Polymethyl Methacrylate, Tricaprylin, Sodium Hydroxide, Xylitol, 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 Acne Balancing Serum Salicylic Acid ALLANTOIN ALOE VERA LEAF CAPRYLIC ACID HYALURONATE SODIUM RESVERATROL XANTHAN GUM EDETATE DISODIUM EDETIC ACID TRICAPRYLIN XYLITOL SALICYLIC ACID SALICYLIC ACID WATER DIMETHYL ISOSORBIDE PROPANEDIOL INDIAN FRANKINCENSE CAPRYLYL GLYCOL OLIGOPEPTIDE-10 HONEY POLY(METHYL METHACRYLATE; 450000 MW) NIACINAMIDE GLYCERYL CAPRATE PENTYLENE GLYCOL SODIUM HYDROXIDE ETHYLHEXYLGLYCERIN GLYCERIN AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER PSEUDOPTEROGORGIA ELISABETHAE RICE BRAN .BETA.-THUJAPLICIN
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 Alumier MD Acne Balancing Serum ACNE TREATMENT WITH 2% SALICYLIC ACID NPN: 80063862 30 mL/1 fl oz acne balancing serum
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. 5 ST. FREDERICK STREET VALLETTA VLT 1470, MALTA WWW.ALUMIERMD.COM EUROPE • UNITED STATES • CANADA UNITED KINGDOM 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, get medical help or contact a Poison Control Centre 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 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, consult a health care professional
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, consult a health care professional Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Centre 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