NDC 69968-0475 Aveeno Anti-itch Concentrated

Zinc Oxide, Ferric Oxide Red, And Pramoxine Hydrochloride

NDC Product Code 69968-0475

NDC Code: 69968-0475

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

  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0475 - Aveeno Anti-itch Concentrated

NDC 69968-0475-4

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Aveeno Anti-itch Concentrated with NDC 69968-0475 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.

Labeler Name: Johnson & Johnson Consumer Inc.

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.

  • ZINC OXIDE 29.4 mg/mL
  • FERRIC OXIDE RED .6 mg/mL
  • PRAMOXINE HYDROCHLORIDE 10 mg/mL

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

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: 69968
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: 03-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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

Distributed by: JOHNSON & JOHNSON CONSUMER INC.Skillman, NJ 08558

Otc - Purpose

Active ingredientsPurposeCalamine 3%Skin ProtectantPramoxine HCl 1%External Analgesic

Uses

  • For temporary relief of pain and itching associated with: minor burnssunburnminor cutsscrapesinsect bites minor skin irritationsrashes due to poison ivy, poison oak, or poison sumacDries the oozing and weeping of poison: ivyoaksumac

Warnings

For external use only.

Do Not Use

  • On wounds or damaged skin

When Using This Product

  • Do not get into eyesdo not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

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

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: ask a doctor.

Other Information

  • Store at Room Temperature

Inactive Ingredients

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

Questions?

Call toll-free 866-428-3366 or 215-273-8755(collect) www.aveeno.com

* Please review the disclaimer below.

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