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Product NDC Code | 51326-179 | ||||
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Drug Name | Dr. gross ab acne daily breakout |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 251577 | ||||
Application Number | M006 | ||||
Labeler Name | Topiderm, Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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 Place a cotton ball over the pump firmly and pump 2 to 3 times to saturate, then cover the affected area once 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 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/Aqua/Eau, Alcohol Denat. (SD Alcohol 40-B), Propylene Glycol, Gluconolactone, Polyglyceryl-10 Laurate, Lactic Acid, Pyruvic Acid, Phytic Acid, Azelaic Acid, Salix Alba (Willow) Bark Extract, Carnitine HCl, Xylitol, Caprylic Acid, Leuconostoc/Radish Root Ferment Filtrate, Farnesol, Tetrahydrocurcumin, Chlorhexidine Gluconate, Soy Isoflavones, Saccharide Isomerate, Zinc PCA, Sodium Hyaluronate, Methyl Glucose Sesquistearate, Neopentyl Glycol Diethylhexanoate, PEG-20 Methyl Glucose Sesquistearate, Glyceryl Stearate, Hexylresorcinol, Dimethyl Isosorbide, Propanediol, C13-15 Alkane, Potassium Hydroxide, Stearic Acid, Citric Acid, Calcium Gluconate, Sodium Citrate, Cucumis Sativus (Cucumber) Fruit Water, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate
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 For the treatment of acne Penetrates pores to eliminate most acne blemishes and blackheads Helps prevent development of new acne blemishes and blackheads
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.Dr. Gross AB Acne Daily Breakout salicylic acid SALICYLIC ACID SALICYLIC ACID WATER GLUCONOLACTONE CARNITINE SALIX ALBA BARK FYTIC ACID LACTIC ACID, DL- PYRUVIC ACID AZELAIC ACID ZINC PIDOLATE ALCOHOL POTASSIUM HYDROXIDE GENISTEIN HEXYLRESORCINOL TETRAHYDROCURCUMIN .BETA.-O-GLUCURONIDE CHLORHEXIDINE GLUCONATE POLYGLYCERYL-10 LAURATE FARNESOL LEVOCARNITINE HYDROCHLORIDE HYALURONATE SODIUM LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE NEOPENTYL GLYCOL DIETHYLHEXANOATE SACCHARIDE ISOMERATE DIMETHYL ISOSORBIDE GLYCERYL MONOSTEARATE METHYL GLUCOSE SESQUISTEARATE PEG-20 METHYL GLUCOSE SESQUISTEARATE CUCUMBER FRUIT OIL XYLITOL CAPRYLIC ACID SODIUM BENZOATE C13-15 ALKANE CALCIUM GLUCONATE TERT-BUTYL ALCOHOL DENATONIUM BENZOATE ANHYDROUS CITRIC ACID SODIUM CITRATE, UNSPECIFIED FORM POTASSIUM SORBATE PHENOXYETHANOL .ALPHA.-TOCOPHEROL STEARIC ACID PROPANEDIOL
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.PRINCIPAL DISPLAY PANEL - 150 ml Bottle Carton Dr Dennis Gross Alpha Beta ® 2% BHA Breakout Solution Salicylic Acid Liquid Acne Treatment You have: Acne including breakouts, clogged pores and uneven tone & texture You want: All over liquid solution that exfoliates, clears & prevents acne, refines pores, evens skin tone and reduces redness 5.0 fl oz/150ml ℮ PRINCIPAL DISPLAY PANEL - 150 ml Bottle Carton
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
Other Information Sunburn Alert This product contains alpha hydroxy acid(s) (AHAs) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. We recommend daily use of a sunscreen, whether or not you use this product, to protect your skin from the risks associated with sun exposure.
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 Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-830-7546 Email [email protected] Monday through Friday, 8:00 AM to 7:00 PM EST
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 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.
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 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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