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Product NDC Code | 68479-782 | ||||
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Drug Name | Clarifying bacne |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
RxCUI drug identifier | 2560235 | ||||
Application Number | M006 | ||||
Labeler Name | Dermalogica, LLC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid (1.0%)
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 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. Hold the spray about a foot and a half away from your body and mist onto clean, dry skin. Let it sink into skin for 30-60 seconds.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Isoceteth-20, Ethoxydiglycol, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Cymbopogon Schoenanthus Oil, Argania Spinosa Kernel Oil, Citrus Reticulata (Tangerine) Leaf Oil, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Oil, Butylene Glycol, Tocopherol, Beta-Sitosterol, Ethylhexylglycerin, Polysorbate 20, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Benzoic Acid, Limonene, Linalool, Citral, Geraniol, Citronellol, Coumarin.
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
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.Clarifying Bacne Salicylic Acid Salicylic Acid Salicylic Acid Water HAMAMELIS VIRGINIANA TOP WATER Isoceteth-20 DIETHYLENE GLYCOL MONOETHYL ETHER Hexylene Glycol Phenoxyethanol Polysorbate 20 ORANGE OIL, COLD PRESSED Sodium Hydroxide TEA TREE OIL Ethylhexylglycerin LAVENDER OIL EDETATE DISODIUM ANHYDROUS Butylene Glycol LEMON OIL, DISTILLED Cymbopogon Schoenanthus Oil ARGAN OIL Benzoic Acid CITRUS AURANTIUM FRUIT OIL SESAME OIL GREEN TEA LEAF GLYCYRRHIZA GLABRA PORPHYRA UMBILICALIS Tocopherol .BETA.-SITOSTEROL SAW PALMETTO LIMONENE, (+)- LINALOOL, (+/-)- CITRAL Geraniol .BETA.-CITRONELLOL, (R)- Coumarin
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 - 177 mL Bottle Label clarifying bacne spray clears + rebalances dermalogica clear start 6 US FL OZ / 177 mL ℮ PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
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
Contents under pressure Do not puncture or incinerate can. Do not store at temperatures above 120°F.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use In or near eyes. If contact occurs, flush thoroughly with water. If irritation develops, discontinue use.
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 or comments Call toll free 1-800-831-5150 in the US
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 are 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. Do not inhale.
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 Do not use In or near eyes. If contact occurs, flush thoroughly with water. If irritation develops, discontinue use. When using this product Skin irritation and dryness are 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. Do not inhale. 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