NDC 22431-135 Sesame Street Baby Oil

Mineral Oil

NDC Product Code 22431-135

NDC 22431-135-01

Package Description: 200 mL in 1 PACKAGE

NDC Product Information

Sesame Street Baby Oil with NDC 22431-135 is a a human over the counter drug product labeled by Blue Cross Laboratories, Inc.. The generic name of Sesame Street Baby Oil is mineral oil. The product's dosage form is oil and is administered via topical form.

Labeler Name: Blue Cross Laboratories, Inc.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Sesame Street Baby Oil 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.

  • MINERAL OIL 99.5 g/100mL

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: Blue Cross Laboratories, Inc.
Labeler Code: 22431
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: 02-12-2019 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’.

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Sesame Street Baby Oil Product Label Images

Sesame Street Baby Oil 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

Otc - Active Ingredient

Active Ingredients      PurposeMineral Oil (99.5)       Prevent chafing

Otc - Purpose

Uses Use Sesame Street Non-irritatiting Baby Oil to help keep skin soft and smooth. Baby Oil is soothing, non-irritating  & helps relieve dryness.

Otc - Keep Out Of Reach Of Children

Keep out of children's reach

Indications & Usage

Avoid drinking and accidental inhalationm which can cause Serious injury, Should Breating problems occur, consult a docitor immediately.

Warnings

WarningsFor external Use only

Dosage & Administration

DirectionsBabies: Apply daily or as necessary to help relieve dry skin or at diaper changeuse as an aid to prevent chafingAdults:user after shower or bath on wet skin as a skin moisturizer. Helps soften dry skin

Inactive Ingredient

Other ingredientsFragrance

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