NDC 63824-424 Clearasil Ultra Rapid Action Treatment

NDC Product Code 63824-424

NDC CODE: 63824-424

Proprietary Name: Clearasil Ultra Rapid Action Treatment What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

NDC Code Structure

NDC 63824-424-01

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC 63824-424-02

Package Description: 1 TUBE in 1 CARTON > 12 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Clearasil Ultra Rapid Action Treatment with NDC 63824-424 is a product labeled by Reckitt Benckiser Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 106315 and 763469.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • AMMONIA (UNII: 5138Q19F1X)
  • ARGININE (UNII: 94ZLA3W45F)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SORBIC ACID (UNII: X045WJ989B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Reckitt Benckiser Llc
Labeler Code: 63824
Start Marketing Date: 06-15-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)

Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
[Read More]

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Clearasil Ultra Rapid Action Treatment Product Label Images

Clearasil Ultra Rapid Action Treatment Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distributed by:Reckitt Benckiser LLCParsippany, NJ 07054-0224

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Use

For the treatment of acne

Warnings

For external use only

Otc - Do Not Use

Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide

Otc - When Using

  • When using this productavoid unnecessary sun exposure and use a sunscreen. avoid contact with the eyes, lips and mouth.avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product.with 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.skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.

Otc - Stop Use

Stop use and ask a doctor if skin irritation becomes severe

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Cleanse the skin thoroughly before applying medication.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.if going outside use a sunscreen. Allow Clearasil ULTRA® Rapid Action Treatment Cream to dry, apply sunscreen after using this product. If irritation or sensitivity develops, discontinue use of both products and ask a doctor.

Other Information

  • Keep tightly closedStore at controlled room temperature 68-77°F (20-25°C)

Inactive Ingredients

Water, gluconolactone, glyceryl stearate, glycerin, PEG-40 stearate, PEG-100 stearate, cetyl alcohol, dimethicone, magnesium aluminum silicate, xanthan gum, benzyl alcohol, ammonium hydroxide, arginine, benzoic acid, sorbic acid, titanium dioxide

Questions?

Call 1-866-25-CLEAR (1-866-252-5327).You may also report side effects to this phone number.

* Please review the disclaimer below.