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| Product NDC Code | 11410-214 | ||||
|---|---|---|---|---|---|
| Drug Name | Proactiv blemish control body cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 248609 | ||||
| Application Number | M006 | ||||
| Labeler Name | Alchemee, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 1.5%
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.Directions Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. clear the skin thoroughly before applying this product. cover the entire affected area with a thin layer and rinse thoroughly one to three times daily because excessive drying of the skin may occur, 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 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, Glycerin, Cetearyl Alcohol, Dicaprylyl Carbonate, Ethoxydiglycol, Cetyl Alcohol, Dimethicone, Propanediol, C12-15 Alkyl Benzoate, Phenoxyethanol, Polysorbate 60, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Tocopheryl Acetate, Ethylhexylglycerin, Sodium Hyaluronate, Tocopherol.
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 management 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.Proactiv Blemish Control Body Cream SALICYLIC ACID WATER GLYCERIN DIMETHICONE ETHYLHEXYLGLYCERIN SODIUM HYDROXIDE PHENOXYETHANOL SALICYLIC ACID SALICYLIC ACID PROPANEDIOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 60 POTASSIUM CETYL PHOSPHATE HYALURONATE SODIUM
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 - 60 mL Carton proactiv BLEMISH CONTROL BODY CREAM CLEARS PORES MOISTURIZES & PROTECTS SKIN ACNE TREATMENT 1.5% salicylic acid 4 FL. OZ. (118 mL) image 1
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
Distributed by Alchemee LLC, Hawthorne, NY 10532 Made in the USA of Foreign and Domestic Components Questions? 1-800-950-4695 • proactiv.com • Proactiv is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at 20-25°C (68 - 77°F)
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? 1-800-950-4695
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. avoid contact with eyes. if contact occurs rinse eyes thoroughly with water.
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. avoid contact with eyes. if contact occurs rinse eyes 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