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| Product NDC Code | 11410-048 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Proactiv deep cleansing wash |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION/SHAMPOO | ||||||||||
| Application Number | M006 | ||||||||||
| Labeler Name | THE PROACTIV COMPANY LLC | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient 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 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. apply a small amount to dampened skin. cover the entire affected area with a thin layer and rinse thoroughly . Shake before use. because excessive drying of the skin may occur, start with one application every other day, then gradually increase to one application daily or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application use to every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Paraffin, Stearyl Alcohol, Cetyl Alcohol, Jojoba Esters, Sodium Chloride, Sodium Methyl Cocoyl Taurate, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Coconut Acid, Menthol, PEG-120 Methyl Glucose Dioleate, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Ascorbic Acid, Citric Acid, Butylene Glycol, Disodium EDTA, Isopropyl Alcohol, Sodium Hydroxide, Phenoxyethanol, Sodium Benzoate, Sodium Sulfite, Potassium Sorbate, Fragrance, Chromium Hydroxide Green Questions or comments? Within US 1-800-950-4695
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 Deep Cleansing Wash Salicylic Acid WATER COCAMIDOPROPYL BETAINE DISTEARYL PHTHALAMIC ACID PARAFFIN STEARYL ALCOHOL CETYL ALCOHOL SODIUM CHLORIDE SODIUM METHYL COCOYL TAURATE ALOE VERA LEAF GREEN TEA LEAF COCONUT ACID MENTHOL PEG-120 METHYL GLUCOSE DIOLEATE CAPRYLYL GLYCOL HEXYLENE GLYCOL ETHYLHEXYLGLYCERIN ASCORBIC ACID CITRIC ACID MONOHYDRATE BUTYLENE GLYCOL EDETATE DISODIUM ISOPROPYL ALCOHOL SODIUM HYDROXIDE PHENOXYETHANOL SODIUM BENZOATE SODIUM SULFITE POTASSIUM SORBATE CHROMIUM HYDROXIDE GREEN HYDROLYZED JOJOBA ESTERS (ACID FORM) SALICYLIC ACID SALICYLIC ACID
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 - 89 mL Carton proactiv ® DEEP CLEANSING WASH 3 FL. OZ. 89 mL salicylic acid acne treatment Dist. by: The Proactiv Company LLC 100 N Sepulveda Blvd., El Segundo, CA 90245 proactiv.com ● Made in the USA of Foreign and Domestic Components Proactiv is a trademark of The Proactiv Company Sàrl. Proactiv Deep Cleansing Wash 89 mL Carton
PRINCIPAL DISPLAY PANEL - 267 mL Tube proactiv ® DEEP CLEANSING WASH 9 FL. OZ. 267 mL salicylic acid acne medication Distributed by The Proactiv Company LLC 100 N Sepulveda Blvd., El Segundo, CA 90245 ● proactiv.com Made in the USA of Foreign and Domestic Components Proactiv is a trademark of The Proactiv Company Sàrl. Proactiv Deep Cleansing Wash 267 mL
PRINCIPAL DISPLAY PANEL - 475 mL Tube proactiv ® DEEP CLEANSING WASH 16 FL. OZ. 475 mL salicylic acid acne medication Proactiv Deep Cleansing Wash 475 mL Tube
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
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.
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 irritation becomes severe.
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 are 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 are 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. Stop use and ask a doctor if irritation becomes severe. 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