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Product NDC Code | 83316-001 | ||||
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Drug Name | Crystal clear acne treatment pads |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 797892 | ||||
Application Number | M006 | ||||
Labeler Name | Skin Pharm, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 2% w/v
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 one to two times daily, avoiding eye area • allow to absorb before applying additional products • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 • do not rinse • tighten cap after use to prevent pads from drying out. • Sensitivity Test for a New User . Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions stated above.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Allantoin, Aloe ( Aloe barbadensis ) leaf extract, Beta-glucan, Caprylic/capric triglyceride, Chamomile ( Chamomilla recutita ) flower extract, Cucumber ( Cucumis sativus ) fruit extract, Dipotassium glycyrrhizate, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Glycolic acid, Grapefruit ( Citrus grandis ) peel extract, Lactic acid, Licorice ( Glycyrrhiza glabra ) root extract, Menthyl lactate, PEG-40 hydrogenated castor oil, Phenoxyethanol, PPG-26-Buteth-26, Sodium hydroxide, Tetrasodium EDTA, Water (Aqua), White mulberry ( Morus alba ) root extract
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.Crystal Clear Acne Treatment Pads Salicylic acid SALICYLIC ACID SALICYLIC ACID ALLANTOIN ALOE VERA LEAF YEAST .BETA.-D-GLUCAN MEDIUM-CHAIN TRIGLYCERIDES CHAMOMILE CUCUMBER GLYCYRRHIZINATE DIPOTASSIUM DIETHYLENE GLYCOL MONOETHYL ETHER ETHYLHEXYLGLYCERIN GLYCERIN GLYCOLIC ACID CITRUS MAXIMA FRUIT RIND LACTIC ACID, UNSPECIFIED FORM GLYCYRRHIZA GLABRA MENTHYL LACTATE, (-)- POLYOXYL 40 HYDROGENATED CASTOR OIL PHENOXYETHANOL PPG-26-BUTETH-26 SODIUM HYDROXIDE EDETATE SODIUM WATER MORUS ALBA ROOT
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.Packaging Acnepad001
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
Manufactured for Skin Pharm, Nashville, TN 37212 skinpharm.com
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? +1-615-582-6726 You may also report serious side effects to this phone number. Mon - Fri, 9:30 AM - 5:30 PM
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at 68° - 77° F • protect from excessive moisture • Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.
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 • 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, lips and mouth. If contact occurs, flush thoroughly with water. 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