NDC 69968-0511 Aveeno Hydrocortisone Anti-itch

Hydrocortisone

NDC Product Code 69968-0511

NDC Code: 69968-0511

Proprietary Name: Aveeno Hydrocortisone Anti-itch Additional informationCallout TooltipWhat 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: Hydrocortisone Additional informationCallout TooltipWhat 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.


Code Structure
  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0511 - Aveeno Hydrocortisone Anti-itch

NDC 69968-0511-1

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

NDC Product Information

Aveeno Hydrocortisone Anti-itch with NDC 69968-0511 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Hydrocortisone Anti-itch is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

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 Additional informationCallout TooltipWhat 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 Hydrocortisone Anti-itch Active Ingredient(s)

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

  • HYDROCORTISONE 10 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • POTASSIUM LACTATE (UNII: 87V1KMK4QV)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • OAT (UNII: Z6J799EAJK)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Hydrocortisone Anti-itch Product Label Images

Aveeno Hydrocortisone Anti-itch 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

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Use

  • For the temporary relief of itching associated with minor skin irritations and rashes due to:eczemainsect bitespoison ivy, oak or sumacsoaps and detergentscosmeticsjewelryseborrheic dermatitispsoriasisOther uses of this product should be only under the advice and supervision of doctor

Warnings

For external use only.

Do Not Use

  • In or near the eyesfor diaper rash; ask a doctor

Otc - Ask Doctor

Ask a doctor before use if you are using any other hydrocortisone product

Stop Use And Ask A Doctor If

  • Condition worsens or if symptoms persists for more than 7 dayssymptoms 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 immediately.

Directions

  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age, do not use; ask a doctor.

Other Information

Protect from Excessive Heat (40°c/104°F)

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin, Isopropyl Myristate, Cetereath-20, Cyclopentasiloxane, Avena Sativa (Oat) Kernel flour, Cetyl Palmitate, Isostearyl Neopentanoate, Benzyl Alcohol, Dimethicone/Vinyltrimethylsiloxysilicate, Crosspolymer, Potassium Lactate, PEG-40 Stearate, Methylparaben, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

Questions?

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

* Please review the disclaimer below.

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