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| Product NDC Code | 78863-1090 | ||||
|---|---|---|---|---|---|
| Drug Name | Therapeutic hydrogel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 317152 | ||||
| Application Number | M006 | ||||
| Labeler Name | Noon Aesthetics M.R. Ltd | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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 Cleanse the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, if needed or as directed by a doctor. Start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness of peeling occurs, reduce application to one a day or every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua, Lactic Acid, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polyacrylate Crosspolymer-6, Isononyl Isononanoate, Ethylhexyl Stearate, Citronellyl Methylcrotonate, Polysorbate 20, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Wheat Straw Glycosides, Cetearyl Alcohol, Cyclopentasiloxane ,Dimethicone, Parfum, Caprylyl Glycol, T-Butyl Alcohol, Sodium Phytate, Xhantan Gum, Sodium Hydroxide
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.Therapeutic Hydrogel Salicylic Acid Salicylic Acid Salicylic Acid Polysorbate 20 Propanediol Water Phytate Sodium Dimethyl Sulfone Strontium Chloride Hexahydrate Xanthan Gum Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.S) Tert-Butyl Alcohol LACTIC ACID, DL- Sodium Hydroxide Cetearyl Wheat Straw Glycosides Cetostearyl Alcohol Isononyl Isononanoate OCTYL STEARATE Cetyl Alcohol Glyceryl Monostearate PEG-100 Stearate Phenoxyethanol Caprylyl Glycol Citronellyl Methylcrotonate Cyclomethicone 5 Dimethicone
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 - 50 gr Bottle Carton NOON ™ Therapeutic Hydrogel with DermShield ™ A Potent Skin Balancer and Moisturizer Intensive Treatment for Oily / Combination Skin Lactic Acid 10% Salicyclic Acid 2 % pH 3.5 PARACEUTICAL 50 gr / 1.76 Oz ℮ PRINCIPAL DISPLAY PANEL - 50 gr 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:
Developed and Dist. by NOON Aesthetics 18th Ahavat Zion TLV, 62153.
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 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? Visit www. noonaesthetics.com or call Toll Free 1-833-666-6246
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 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat and direct sun.
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. Keep out of reach of children. If swallowed, get 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