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| Product NDC Code | 69473-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Alumier md acne clarifying cleanser |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 562600 | ||||
| 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 use twice daily, in the morning and evening moisten face with lukewarm water pump a small amount into your hand add water and apply to your face and neck, massaging in a circular motion rinse thoroughly with lukewarm water and gently pat dry 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, Sodium C14-16 Olefin Sulfonate, Propanediol, Dimethyl Lauramide/Myristamide, Glycerin, Cocamidopropyl Dimethylamine, Cocamidopropyl Hydroxysultaine, Glyceryl Caprate, Lauryl Lactyl Lactate, Oligopeptide-10, Aloe Barbadensis Leaf Juice, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa (Rice) Bran Extract, Carbomer, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Caprylic 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 Acne Clarifying Cleanser Salicylic Acid SALICYLIC ACID SALICYLIC ACID CAPRYLIC ACID PROPANEDIOL COCAMIDOPROPYL HYDROXYSULTAINE GLYCERYL CAPRATE OLIGOPEPTIDE-10 HONEY EDETATE DISODIUM EDETIC ACID COCAMIDOPROPYL DIMETHYLAMINE ALOE VERA LEAF CAPRYLYL GLYCOL GLYCERIN RICE BRAN CARBOXYPOLYMETHYLENE SODIUM HYDROXIDE XYLITOL ETHYLHEXYLGLYCERIN INDIAN FRANKINCENSE WATER SODIUM C14-16 OLEFIN SULFONATE
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 Clarifying Cleanser ACNE TREATMENT WITH 2% SALICYLIC ACID NPN: 80064465 177 mL/6 fl oz acne clarifying cleanser rev
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, 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 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, 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