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Product NDC Code | 68479-101 | ||||||||||
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Drug Name | Breakout clearing foaming wash |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | LIQUID | ||||||||||
Application Number | part358H | ||||||||||
Labeler Name | Dermalogica | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid (0.5%).
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 Morning and night, work a pea-sized amount into a lather in wet hands. Apply to dampened face and neck, massaging in circular motions while concentrating on areas of congestion and oiliness. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two daily. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Avoid eye area. Rinse thoroughly with warm water.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua/Eau, Cocamidopropyl Betaine, Sodium Lauroyl Methyl Isethionate, Acrylates/Beheneth-25 Methacrylate Copolymer, Polysorbate 20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Oleanolic Acid, Butylene Glycol, Enantia Chlorantha Bark Extract, Disodium Cocoamphodiacetate, Spiraea Ulmaria Extract, Camellia Sinensis Leaf Extract, Porphyra Umbilicalis Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.
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.Breakout Clearing Foaming Wash Salicylic Acid Salicylic Acid Salicylic Acid WATER COCAMIDOPROPYL BETAINE SODIUM LAUROYL METHYL ISETHIONATE POLYSORBATE 20 TEA TREE OIL ORANGE OIL, COLD PRESSED LAVENDER OIL OLEANOLIC ACID BUTYLENE GLYCOL ANNICKIA CHLORANTHA BARK DISODIUM COCOAMPHODIACETATE FILIPENDULA ULMARIA ROOT GREEN TEA LEAF PORPHYRA UMBILICALIS GLYCYRRHIZA GLABRA SODIUM HYDROXIDE ETHYLHEXYLGLYCERIN PHENOXYETHANOL
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 - 295 mL Bottle Label breakout clearing foaming wash dermalogica clear start deep cleans + purifies 10 US FL OZ / 295 mL ℮ PRINCIPAL DISPLAY PANEL - 295 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
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 around eye area. If contact occurs, flush thoroughly with water.
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.
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 around eye area. If contact occurs, flush thoroughly with water. 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. 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