NDC 69748-641 Neutracure Restore

Benzoyl Peroxide

NDC Product Code 69748-641

NDC CODE: 69748-641

Proprietary Name: Neutracure Restore 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.

Non-Proprietary Name: Benzoyl Peroxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat mild to moderate acne. It may be used in combination with other acne treatments. When applied to the skin, benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 69748 - Neutracure

NDC 69748-641-01

Package Description: 59 mL in 1 JAR

NDC Product Information

Neutracure Restore with NDC 69748-641 is a a human over the counter drug product labeled by Neutracure. The generic name of Neutracure Restore is benzoyl peroxide. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 308693.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Neutracure Restore Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Neutracure
Labeler Code: 69748
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-10-2015 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: 12-31-2021 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: N - NO 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....
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Neutracure Restore Product Label Images

Neutracure Restore 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

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Medication

Uses

  • Fot the treatment of acneuse to prevent new pimples from forming

Warnings

For external use only

Do Not Use If

If you have very sensitive skin or are sensitive to benzoyl peroxide.

When Using This Product

  • Avoid unnecessary sun exposure and use a sunscreenavoid contact with the eyes, lips and mouthavoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this productwith other topical acne medications, at the same time ot immediately following use of this product. Increased dryness or imitation may occur. If this occurs, only one medication should be used unless directed by a doctor.skin imitation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate skin imitation. Mild imitation may be reduced by using the product less frequently or in a lower concentration.

Stop Use And Ask A Doctor

If skin irritation becomes severe

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • Cleanse the skin thoroughly before applying medicationcover the entire affected area with a thin layer one to three times a daybecause 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 dayIf going outside use a sunscreen. Allow Acne Treatment Cream to dry, then follow directions in sunscreen labeling . If sensitivity develops, discontinue use of both products and ask a doctor

Other Information

  • Keep tightly closedkeep away from heat

Inactive Ingredients:

ALLANTOIN, ALOE BARBADENSIS LEAF (ALOE VERA GEL) JUICE, BENZYL ALCOHOL, BETULA ALBA (BIRCH) EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CARBOMER, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) OIL, DMDM HYDANTOIN,


GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL), IODOPROPYNYL BUTYLCARBAMATE, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHOL,


METHYLISOTHIAZOLINONE, PARFUM (FRAGRANCE), POLYSORBATE-20, SACCHARUM OFFICINALIS (SUGAR) CANE EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, SALVIA OFFICINALIS (SAGE) EXTRACT, SODIUM CITRATE, SODIUM HYALURONATE (HYALURONIC ACID), SODIUM HYDROXIDE,


TRIETHANOLAMINE, VACCINIUM MYRTILLUS (BILBERRY) EXTRACT, XANTHAN GUM

* Please review the disclaimer below.