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Proactiv plus complexion perfecting hydrator - Medication Information

Product NDC Code 11410-023
Drug Name

Proactiv plus complexion perfecting hydrator

Type Brand
Active Ingredients
Salicylic acid .5 g/100ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 248684
Application Number M006
Labeler Name Alchemee, LLC
Packages
Package NDC Code Description
11410-023-00 1 tube in 1 box (11410-023-00) / 30 ml in 1 tube
11410-023-05 1 jar in 1 box (11410-023-05) / 89 ml in 1 jar
11410-023-10 1 tube in 1 box (11410-023-10) / 89 ml in 1 tube
11410-023-15 89 ml in 1 tube (11410-023-15)
11410-023-20 1 tube in 1 carton (11410-023-20) / 10 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 0.5%

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. 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, butylene glycol, cetearyl alcohol, dimethicone, sodium polyacrylate, glycerin, ceteareth-20, ethylhexyl palmitate, polysorbate 60, hydrogenated polydecene, aluminum starch octenylsuccinate, PPG-2 myristyl ether propionate, phenoxyethanol, alpha-glucan oligosaccharide, squalane, caprylic/capric triglyceride, caprylyl glycol, zinc gluconate, C12-15 alkyl lactate, morus alba root extract, hexylene glycol, ethylhexylglycerin, bisabolol, safflower oil/palm oil aminopropanediol esters, allantoin, PPG-5-laureth-5, sodium hydroxide, kojic acid, hydroxypropyl cyclodextrin, sophora angustifolia root extract, disodium EDTA, fragrance, polyquaternium-11, glycyrrhiza glabra (licorice) root extract, arctostaphylos uva ursi leaf extract, scutellaria baicalensis root extract, sodium hyaluronate

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 Plus Complexion Perfecting Hydrator SALICYLIC ACID EDETATE DISODIUM PHENOXYETHANOL ADRABETADEX HYDROGENATED POLYDECENE TYPE I SALICYLIC ACID SALICYLIC ACID WATER BUTYLENE GLYCOL CETOSTEARYL ALCOHOL DIMETHICONE SODIUM POLYACRYLATE (8000 MW) SCUTELLARIA BAICALENSIS ROOT SOPHORA FLAVESCENS ROOT MORUS ALBA ROOT GLYCYRRHIZA GLABRA ARCTOSTAPHYLOS UVA-URSI LEAF KOJIC ACID ZINC GLUCONATE .ALPHA.-GLUCAN OLIGOSACCHARIDE HYALURONATE SODIUM LEVOMENOL ALLANTOIN SQUALANE C12-15 ALKYL LACTATE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN GLYCERIN ETHYLHEXYL PALMITATE POLYQUATERNIUM-11 (1000000 MW) POLYOXYL 20 CETOSTEARYL ETHER ALUMINUM STARCH OCTENYLSUCCINATE POLYSORBATE 60 HEXYLENE GLYCOL PPG-2 MYRISTYL ETHER PROPIONATE SODIUM HYDROXIDE

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 proactiv+ Complexion Perfecting Hydrator 3 FL. OZ. 89 mL salicylic acid acne treatment unit 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 Distributed by Alchemee LLC Santa Monica, CA 90401 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.

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

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