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Product NDC Code | 70317-146 | ||||
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Drug Name | So clear cleanse acne cleanser |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 389122 | ||||
Application Number | M006 | ||||
Labeler Name | RemeVerse | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.So Clear Cleanse Acne Cleanser Benzoyl Peroxide
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 Starting with clean hands, apply to face, nose, or ears and gently rub in. Apply 1 -2 times daily. Discontinue use if increased irritation occurs.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.So Clear Cleanse Acne Cleanser Water, Disodium Laureth Sulfosuccinate, Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Acrylates Copolymer, Magnesium Aluminum Silicate, Sodium Xylenesulfonate, Montan Wax, Glycolic Acid, Sodium C14-16 Alpha Olefin Sulfonate, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol
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 management of acne
Purpose
Information about the drug product’s indications for use.So Clear Cleanse Acne Cleanser Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.So Clear Cleanse Acne Cleanser Benzoyl Peroxide GLYCOLIC ACID SODIUM XYLENESULFONATE MONTAN WAX BENZOYL PEROXIDE BENZOYL PEROXIDE ACRYLATES CROSSPOLYMER-6 DISODIUM LAURETH SULFOSUCCINATE SODIUM COCOYL ISETHIONATE SODIUM C14-16 OLEFIN SULFONATE SODIUM HYDROXIDE MAGNESIUM ALUMINUM SILICATE
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.So Clear Cleanser So Clear Cleanse
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Label Deleted image of So Clear Cleanse label OTC drug panel (002).jpg and inserted new image of So Clear Cleanse label OTC drug panel (003).jpg So Clear Cleanse label OTC drug panel (003).jpg This new label change is the name of product at the top of image to SO Clear Cleanse Acne Cleanser Erased from WARNING SECTION "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." AND added same language removed to OTC - KEEP OUT OF REACHOF CHILDREN section.
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.Store at room temperature. Avoid high excessive heat. (99 degrees F)
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 the reach of Children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop Use Section Stop use and ask a doctor if skin irritation becomes severe.
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 this medication if you are sensitive to Benzoyl Peroxide. When using this product § Avoid unnecessary sun exposure and use a sunscreen. § Avoid contact with eyes, lips and mouth. § 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. Skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling. Irritation may be reduced by using this product less frequently or in a lower concentration. Stop use and ask a doctor if skin irritation becomes severe.
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