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| Product NDC Code | 54111-112 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Broda acne |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 346298, 1543172 |
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| Application Number | M006 | ||||||
| Labeler Name | Bentley Laboratories, LLC | ||||||
| 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.Drug Facts Active Ingredient Salicylic acid 2%
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 Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome 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, poloxamer 407, propylene glycol, PEG-400, laureth-4, menthol, bisabolol.
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 Acne treatment and helps prevent new acne blemishes.
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.BRODA Acne SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID WATER POLOXAMER 407 PROPYLENE GLYCOL POLYETHYLENE GLYCOL 400 LAURETH-4 MENTHOL LEVOMENOL
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.BRODA Acne Spot Treatment and Acne Treatment Pen Labels Tough on acne Gentle on your skin Anti-acne IntelliGel™ BRODA Acne Spot Treatment Broda Acne Treatment Pen IntelliGel™ Technology Suitable for sensitive skin Maximum strength with 2% beta hydrox acid Forms TrueSkin invisible patch No peeling or flaking Won't dry your skin Alcohol-free Hydrogel NET WT. 0.071 oz. (2g) - 0.71 oz. (20 g) Distributed by: Broda International, LLC 10 Barley Court Plainsboro, NJ 08536 Manufactured and packaged in the USA www.broda.com Patent pending BRODA™ Anti-acne IntelliGel™ Developed with a proprietary break-through IntellGel™ technology that delivers maximum strength acne medication to effectively penetrate pores to clear most acne blemishes and help prevent new acne pimples. res BrodaAcneSpot1 Label Broda AcneSpot2 Label Broda AcneSpot3 Label
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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush 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 For external use only.
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