NDC 69968-0540 Aveeno Baby Eczema Therapy Nighttime Balm

Oatmeal

NDC Product Code 69968-0540

NDC Code: 69968-0540

Proprietary Name: Aveeno Baby Eczema Therapy Nighttime Balm 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: Oatmeal 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.
    • 69968-0540 - Aveeno Baby Eczema Therapy Nighttime Balm

NDC 69968-0540-1

Package Description: 312 g in 1 JAR

NDC 69968-0540-5

Package Description: 156 g in 1 JAR

NDC Product Information

Aveeno Baby Eczema Therapy Nighttime Balm with NDC 69968-0540 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Baby Eczema Therapy Nighttime Balm is oatmeal. 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 Baby Eczema Therapy Nighttime Balm 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.

  • OATMEAL 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ISOCETYL ALCOHOL (UNII: 1800H64066)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
  • POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
  • P-ANISIC ACID (UNII: 4SB6Y7DMM3)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • CERAMIDE NP (UNII: 4370DF050B)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • OAT (UNII: Z6J799EAJK)

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: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-25-2019 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: 12-31-2020 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 Baby Eczema Therapy Nighttime Balm Product Label Images

Aveeno Baby Eczema Therapy Nighttime Balm 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

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

  • Temporarily protects and helps relieve minor skin irritation and itching due to:eczemarashes

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.

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

  • Apply as needed.

Other Information

  • Do not use if quality seal is broken or missing.Protect from Excessive Heat (40°C/104°F).

Inactive Ingredients

Glycerin, Water, Cetearyl Alcohol, Isocetyl Alcohol, Dimethicone, Cetyl Alcohol, Benzyl Alcohol, Ethylhexylglycerin, Sodium Cetearyl Sulfate, Benzoic Acid, Stearic Acid, Dipotassium Phosphate, Potassium Phosphate, p-Anisic Acid, Caprylic/Capric Triglyceride, Sodium Hydroxide, Avena Sativa (Oat) Kernel Oil, Ceramide NP, Citric Acid, Avena Sativa (Oat) Kernel Extract

* Please review the disclaimer below.

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