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Proactiv clean acne clearing hydrator - Medication Information

Product NDC Code 11410-458
Drug Name

Proactiv clean acne clearing hydrator

Type Brand
Active Ingredients
Salicylic acid 2 mg/100ml
Route TOPICAL
Dosage Form GEL
Application Number M006
Labeler Name Alchemee, LLC
Packages
Package NDC Code Description
11410-458-00 1 tube in 1 box (11410-458-00) / 10 ml in 1 tube
11410-458-05 30 ml in 1 tube (11410-458-05)
11410-458-10 1 tube in 1 box (11410-458-10) / 30 ml in 1 tube
11410-458-15 1 tube in 1 box (11410-458-15) / 89 ml in 1 tube
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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. clean 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, 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, Glyceryl Stearate SE, Propanediol, Cetyl Phosphate, Cetyl Alcohol, Stearic Acid, Dicaprylyl Carbonate, Undecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Pentylene Glycol, Cetearyl Alcohol, Tridecane, Bakuchiol, Caprylyl Glycol, Xanthan Gum, Ethylhexylglycerin, Tocopheryl Acetate, Sodium Hyaluronate, Phenoxyethanol, 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 Clean Acne Clearing Hydrator Salicylic Acid WATER GLYCERIN PROPANEDIOL CETYL PHOSPHATE CETYL ALCOHOL STEARIC ACID DICAPRYLYL CARBONATE UNDECANE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) PENTYLENE GLYCOL CETOSTEARYL ALCOHOL TRIDECANE BAKUCHIOL GLYCERYL MONOSTEARATE CAPRYLYL GLYCOL XANTHAN GUM ETHYLHEXYLGLYCERIN .ALPHA.-TOCOPHEROL ACETATE HYALURONATE SODIUM TOCOPHEROL SODIUM HYDROXIDE PHENOXYETHANOL 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 - 3 FL. OZ. (89 mL) proactiv® proactiv clean TM Acne Clearing Hydrator 3 FL. OZ. (89 mL) salicylic acid acne treatment unit carton image

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. Santa Monica, CA 90401 Questions or comments? 1-800-950-4695 proactiv.com Made in the USA of foreign and domestic components. Proactiv is a 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.

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