NDC 68786-232 Lanolin

Lanolin

NDC Product Code 68786-232

NDC 68786-232-01

Package Description: 2 BOX in 1 CASE > 144 PACKET in 1 BOX > 5 g in 1 PACKET

NDC 68786-232-02

Package Description: 4 BOX in 1 CASE > 36 PACKET in 1 BOX > 15 g in 1 PACKET

NDC 68786-232-03

Package Description: 36 JAR in 1 CASE > 71 g in 1 JAR

NDC 68786-232-04

Package Description: 24 TUBE in 1 CASE > 114 g in 1 TUBE

NDC 68786-232-05

Package Description: 24 JAR in 1 CASE > 71 g in 1 JAR

NDC 68786-232-06

Package Description: 12 JAR in 1 CASE > 396.8 g in 1 JAR

NDC Product Information

Lanolin with NDC 68786-232 is a a human over the counter drug product labeled by Sion Biotext Medical Ltd. The generic name of Lanolin is lanolin. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Sion Biotext Medical Ltd

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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 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.

Lanolin 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.

  • LANOLIN 50 g/100g

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.

  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • OXYQUINOLINE (UNII: 5UTX5635HP)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • WATER (UNII: 059QF0KO0R)

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: Sion Biotext Medical Ltd
Labeler Code: 68786
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: 07-09-2012 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Lanolin Product Label Images

Lanolin 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 ingredient               Purpose            Lanolin USP 50%                    Skin Protectant

Uses:

  • Helps prevent and treat diaper dermatitisProtects chafed skin or minor skin irritations due to incontinence and helps seal out wetness

Warnings

For External Use Only

Indications And Usage

  • Avoid contact with eyesDo not apply to deep or puncture woundsIf condition worsens, or does not improve within 7 days, consult a doctorIf swallowed, get medical help or contact a Poison Control Center right away

Directions:

  • Gently cleanse and dry areaApply liberally to affected area as needed

Inactive Ingredient

Inactive Ingredients: Beeswax, Fragrance, HEEDTA, Lanolin alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified water, Sodium borate, Sesquioleate

Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

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