NDC 53329-042 Soothe And Cool Free Medseptic Skin Protectant

Lanolin

NDC Product Code 53329-042

NDC 53329-042-44

Package Description: 113 g in 1 JAR

NDC 53329-042-77

Package Description: 14 g in 1 TUBE

NDC Product Information

Soothe And Cool Free Medseptic Skin Protectant with NDC 53329-042 is a a human over the counter drug product labeled by Medline Industries, Inc.. The generic name of Soothe And Cool Free Medseptic Skin Protectant is lanolin. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 853167.

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.

Soothe And Cool Free Medseptic Skin Protectant 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • OXYQUINOLINE (UNII: 5UTX5635HP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • WATER (UNII: 059QF0KO0R)
  • CORN OIL (UNII: 8470G57WFM)

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: Medline Industries, Inc.
Labeler Code: 53329
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: 01-01-2007 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".

* Please review the disclaimer below.

Soothe And Cool Free Medseptic Skin Protectant Product Label Images

Soothe And Cool Free Medseptic Skin Protectant 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

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Use

  • Protects and helps relieve the symptoms of minor skin irritation helps seal out wetness
  • Emollient

Warnings

For external use only

When Using This Product

  • Do not use in or near the eyes

Do Not Use

  • Ondeep or puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days, or clear upand occur again within a few days.

Keep Out Of Reach Of Children.

If swallowedget medical help or contact a Poison Control right away.

Directions

Gently cleanse and dry affected area.Apply liberally to affected area as needed.

Other Information

Protect from freezing.Avoid excessive heat.

Inactive Ingredients

Aloe Barbadensis Leaf JuiceBeeswaxCholecalciferolDisodium EDTAMethylparabenOxyquinoline, PetrolatumPropylparabenRetinyl PalmitateSodium BorateSorbitan SesquioleateTocopherolWaterZea Mays (Corn) Oil

* Please review the disclaimer below.