NDC 58232-9910 Aveeno Anti Itch Concentrated

Zinc Oxide, Ferric Oxide Red, And Pramoxine Hydrochloride

NDC Product Code 58232-9910

NDC CODE: 58232-9910

Proprietary Name: Aveeno Anti Itch Concentrated 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: Zinc Oxide, Ferric Oxide Red, And Pramoxine Hydrochloride 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.

NDC Code Structure

  • 58232 - Johnson & Johnson Consumer Inc.

NDC 58232-9910-2

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Aveeno Anti Itch Concentrated with NDC 58232-9910 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Anti Itch Concentrated is zinc oxide, ferric oxide red, and pramoxine hydrochloride. The product's dosage form is lotion and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1233698.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Aveeno Anti Itch Concentrated 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.

  • OAT (UNII: Z6J799EAJK)
  • OATMEAL (UNII: 8PI54V663Y)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)

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: Johnson & Johnson Consumer Inc.
Labeler Code: 58232
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-07-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-01-2023 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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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Aveeno Anti Itch Concentrated Product Label Images

Aveeno Anti Itch Concentrated 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

Dist. by: Johnson & JohnsonConsumer Products CompanyDivision of Johnson & JohnsonConsumer Companies, Inc.Skillman, NJ 08558-9418

Otc - Purpose

Active ingredientPurposesCalamine (3.%)Skin ProtectantPramoxine HCl (1%)External Analgesic

Uses

  • For temporary relief of pain and itching associated with minor burns, sunburns, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak or poison sumac.Dries the oozing and weeping of poison ivy/oak/sumac

Warnings

For external use only.

When Using This Product

  • Do not get into eyes

Stop Use And Ask A Doctor If

  • Condition worsensSymptoms last more than 7 days or clear up and occur again within a few days discontinue use and consult a doctor.Do not apply to wounds or damaged skin.Do not bandage tightly.

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

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Other Information

Store at room temperature

Inactive Ingredients

Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Oil, Camphor, Cetyl Alcohol, Dimethicone, Distearyldimonium Chloride, Glycerin, Isopropyl Palmitate, Methylparaben, Petrolatum, Sodium Chloride, Water

Questions?

1-866-428-3366

* Please review the disclaimer below.