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Product NDC Code | 51326-307 | ||||
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Drug Name | Topicals clearly mist |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1048903 | ||||
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 Spray a thin layer onto clean skin 1-3 times daily. Allow product to sink in for 30-60 seconds and do not rub in. 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., Hypochlorous Acid, Glycolic Acid, Allantoin, Zinc PCA, Potassium Hydroxide, Sodium Benzoate
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.Topicals Clearly Mist Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER ALCOHOL HYPOCHLOROUS ACID GLYCOLIC ACID ALLANTOIN ZINC PIDOLATE POTASSIUM HYDROXIDE SODIUM BENZOATE
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 - 100 ml Bottle Carton CLEARLY TOPICALS Clarifying & Calming Mist For acne-prone skin 100 ml / 3.4 fl oz PRINCIPAL DISPLAY PANEL - 100 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
Dist. by Topicals Santa Monica, CA 90405
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? +1-323-776-1963
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, keep away from face. If contact occurs, flush thoroughly with water. If irritation occurs when using two acne topical medications, only use one topical acne medication at a time. Do not inhale.
Storage and handling
Information about safe storage and handling of the drug product.Other information Do not store at temperatures above 120°F.
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, keep away from face. If contact occurs, flush thoroughly with water. If irritation occurs when using two acne topical medications, 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