NDC 69968-0593 Aveeno Baby Bathtime Solutions Baby And Mommy Gift Set

Dimethicone

NDC Product Code 69968-0593

NDC Code: 69968-0593

Proprietary Name: Aveeno Baby Bathtime Solutions Baby And Mommy Gift Set 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: Dimethicone 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.
    • 69968-0593 - Aveeno Baby Bathtime Solutions Baby And Mommy Gift Set

NDC 69968-0593-1

Package Description: 1 KIT in 1 CONTAINER * 236 mL in 1 BOTTLE * 354 mL in 1 BOTTLE * 227 mL in 1 TUBE (69968-0441-8) * 236 mL in 1 BOTTLE

NDC Product Information

Aveeno Baby Bathtime Solutions Baby And Mommy Gift Set with NDC 69968-0593 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Baby Bathtime Solutions Baby And Mommy Gift Set is dimethicone. The product's dosage form is kit and is administered via form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • OATMEAL (UNII: 8PI54V663Y)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ALLANTOIN (UNII: 344S277G0Z)

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: part347 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: 06-16-2019 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 Baby Bathtime Solutions Baby And Mommy Gift Set Product Label Images

Aveeno Baby Bathtime Solutions Baby And Mommy Gift Set 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

Dimethicone 1.2%

Purpose

Skin Protectant

Uses

  • Helps prevent and temporarily protects chafed, chapped or cracked skin

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

Do Not Use On

  • Deep or puncture woundsAnimal bitesSerious burns

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

  • Remove quality seal. Do not use if quality seal is broken.Store at room temperature.

Inactive Ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

* Please review the disclaimer below.

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