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| Product NDC Code | 71899-070 | ||||
|---|---|---|---|---|---|
| Drug Name | Itk body blemish treatment mist |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| Application Number | M006 | ||||
| Labeler Name | MAESA, LLC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 Clean skin thoroughly before applying. Use morning or night. Close eyes and mist onto clean, dry skin. Wait 20 – 30 seconds to dry before dressing or applying other products.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua/Eau), Alcohol Denat., Butylene Glycol, PPG-26- Buteth-26, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Glycerin, Mentha Piperita (Peppermint) Oil, Sodium Hydroxide, Glycyrrhiza Glabra (Licorice) Root Extract, Menthol, tert-Butyl Alcohol, Denatonium Benzoate, Limonene, Linalool.
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.
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.ITK Body Blemish Treatment Mist Salicylic Acid Salicylic Acid Salicylic Acid DENATONIUM BENZOATE WATER ALCOHOL BUTYLENE GLYCOL PPG-26-BUTETH-26 POLYOXYL 40 HYDROGENATED CASTOR OIL PHENOXYETHANOL GLYCERIN PEPPERMINT OIL SODIUM HYDROXIDE GLYCYRRHIZA GLABRA MENTHOL, UNSPECIFIED FORM TERT-BUTYL ALCOHOL LIMONENE, (+)- LINALOOL, (+/-)-
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 itk SCAN ME BLEMISH TREATMENT MIST treats acne + controls daily oil 3.3 FL. OZ. / 100 mL 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 Maesa LLC, New York, NY 10281
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, Comments YOU MAY REPORT AN ADVERSE REACTION TO: ITK C/O REPORT REACTION LLC, PO BOX 22, PLAINSBORO, NJ 08536-0222.
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 and ask a doctor if rash occurs. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
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 and other topical acne medications at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor.
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. Flammable: Do not use near heat, flame, or while smoking. When using this product and other topical acne medications at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor. Stop use and ask a doctor if rash occurs. Avoid contact with eyes. 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