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Product NDC Code | 83696-100 | ||||
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Drug Name | Soluclear - acne treatment serum |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | M006 | ||||
Labeler Name | Respect Manufacturing Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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.Clean the skin thoroughly before applying Cover the entire affected area with a thin layer 1-3 times daily. Because excessive drying of the skin may occur, start with one application daily, with a thin layer 1-3 times daily if needed or as directed by doctor. If bothersome dryness or peeling occurs, reduce application to once a day or everyother day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Polyoxyethylene-Polyoxypropylene, Water Soluable Hemp Extract (2.0%), Germall Plus (natural preservative), Vitamin C, Peppermint Fragrance
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 • acne pimples • black & whiteheads
Purpose
Information about the drug product’s indications for use.Acne Medication
Spl product data elements
Usually a list of ingredients in a drug product.SoluClear - Acne Treatment Serum Salicylic Acid HEMP SALICYLIC ACID SALICYLIC ACID PROPYLENE GLYCOL WATER DIAZOLIDINYL UREA ASCORBIC ACID FRAGRANCE PEPPERMINT ORC2000647 PEG/PPG-4/30 COPOLYMER IODOPROPYNYL BUTYLCARBAMATE
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.Front Panel SoluClear Powered by Thermal Fusion Acne Treatment Serum Treat Eliminate Prevent For all Skin Types Made in the USA Water Soluable Hemp Extract 2.0% Salicylic Acid 0.5% 1 oz (30 ml) Side Panels Thermal Fusion Our thermal fusion technology guarantees 100% penetration of potent acne-fighting ingredients deep into your skin, directly targeting breakouts at their source. While traditional emulsion-based treatments achieve only about 10% penetration, SoluClear delivers up to 10x more active ingredients where they-re needed most. Harnessing your natural body temperature, Soluclear's unique subdermal delivery system ensures precise, deep action against acne, eliminating it effectively and efficiently. Say goodbye to surface-level solutions and hello to a clear, healthy looking complexion. Target Acne Treat Eliminate Prevent Non GMO Lab Tested Made in USA Paraben Free Cruelty Free Vegan Back Distributed by: MRC Marketing, LLC 16595 W. Stratton Dr. New Berlin, WI 53151 Primary Label Seconday Label (outermost)
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.If swallowed get medical help or contact a Poison Control Center immediately.
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.• 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.
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.For external use only
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