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| Product NDC Code | 51326-057 | ||||
|---|---|---|---|---|---|
| Drug Name | Dr. dennis gross alpha beta on the spot eliminator |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 346298 | ||||
| Application Number | M006 | ||||
| Labeler Name | Topiderm, Inc | ||||
| 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%
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 occur, 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), Hamamelis Virginiana (Witch Hazel) Water, PVM/MA Decadiene Crosspolymer, Butylene Glycol, Dimethyl Isosorbide, Glycerin, Potassium Hydroxide, Polysorbate 20, Carnitine HCl, Gluconolactone, Phytic Acid, Glycolic Acid, Silybum Marianum Fruit Extract, Bisabolol, Vitex Agnus-Castus Extract, Ganoderma Lucidum (Mushroom) Extract, Vitis Vinifera (Grape) Seed Extract, Tetrahydrocurcumin, Glutathione, Potassium Azeloyl Diglycinate, Farnesol, Leuconostoc/Radish Root Ferment Filtrate, Sodium Pantothenate, Retinol, Niacinamide, Saccharide Isomerate, Ferulic Acid, Camellia Sinensis Leaf Extract, Glyceryl Stearate, Mannitol, sh-Oligopeptide-1, Methyl Glucose Sesquistearate, Neopentyl Glycol Diethylhexanoate, PEG-20 Methyl Glucose Sesquistearate, Aloe Barbadensis Leaf Juice, Centella Asiatica Extract, Phospholipids, Sodium Hyaluronate, Soy Isoflavones, Chamomilla Recutita (Matricaria) Flower Extract, Polyglyceryl-10 Laurate, Zinc PCA, Ethylhexylglycerin, Allantoin, Ethoxydiglycol, Stearic Acid, Citric Acid, Sodium Citrate, Calcium Gluconate, Potassium Gluconate, Cyclodextrin, Tetrasodium Glutamate Diacetate, Caprylic/Capric Triglyceride, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Eugenia Caryophyllus (Clove) Flower Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, 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. Dennis Gross Alpha Beta On the Spot Eliminator Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER ALCOHOL HAMAMELIS VIRGINIANA LEAF WATER BUTYLENE GLYCOL DIMETHYL ISOSORBIDE GLYCERIN POTASSIUM HYDROXYCITRATE POLYSORBATE 20 CARNITINE HYDROCHLORIDE, (+)- GLUCONOLACTONE FYTIC ACID GLYCOLIC ACID SILYBUM MARIANUM WHOLE .ALPHA.-BISABOLOL, (+)- VITEX AGNUS-CASTUS LEAF REISHI TETRAHYDRODIFERULOYLMETHANE GLUTATHIONE POTASSIUM AZELOYL DIGLYCINATE FARNESOL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE SODIUM PANTOTHENATE RETINOL NIACINAMIDE SACCHARIDE ISOMERATE FERULIC ACID GREEN TEA LEAF GLYCERYL MONOSTEARATE MANNITOL NEPIDERMIN METHYL GLUCOSE SESQUISTEARATE ALOE VERA LEAF CENTELLA ASIATICA LEAF HYALURONATE SODIUM GENISTEIN MATRICARIA CHAMOMILLA LEAF POLYGLYCERYL-10 LAURATE ZINC PIDOLATE ETHYLHEXYLGLYCERIN ALLANTOIN DIETHYLENE GLYCOL MONOETHYL ETHER STEARIC ACID CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM CALCIUM GLUCONATE POTASSIUM GLUCONATE CYCLODEXTRINS TETRASODIUM GLUTAMATE DIACETATE MEDIUM-CHAIN TRIGLYCERIDES JASMINUM OFFICINALE FLOWER VITIS VINIFERA FRUIT OIL CLOVE LEAF OIL PHENOXYETHANOL SODIUM BENZOATE POTASSIUM SORBATE
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 - 30 ml Tube Box Dr Dennis Gross Alpha Beta ® On The Spot Eliminator 2% Salicylic Acid Acne Treatment Gel You have: Individual pimples, blemishes, regional breakouts and inflammation You want: A fast-acting spot treatment that reduces pimples, blackheads & whiteheads while soothing redness and irritation 1.0 fl oz/30 ml ℮ PRINCIPAL DISPLAY PANEL - 30 ml Tube Box
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