NDC 52000-073 Diaper Rash Skin Protectant

Lanolin And Petrolatum

NDC Product Code 52000-073

NDC 52000-073-02

Package Description: 1 TUBE in 1 CARTON > 35.4 g in 1 TUBE (52000-073-01)

NDC Product Information

Diaper Rash Skin Protectant with NDC 52000-073 is a a human over the counter drug product labeled by Universal Distribution Centre Llc. The generic name of Diaper Rash Skin Protectant is lanolin and petrolatum. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Universal Distribution Centre Llc

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.

Diaper Rash 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.

  • LANOLIN 136.4 mg/g
  • PETROLATUM 469.9 mg/g

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.

  • COD LIVER OIL (UNII: BBL281NWFG)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • PARAFFIN (UNII: I9O0E3H2ZE)

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: Universal Distribution Centre Llc
Labeler Code: 52000
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: 01-25-2021 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: 12-31-2022 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.

Diaper Rash Skin Protectant Product Label Images

Diaper Rash 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

Other

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

Otc - Purpose

Active ingredientsPurposeLanolin 15.5%Diaper rash ointmentPetrolatum 53.4%Skin Protectant

Uses

  • Helps treat and prevent diaper rashtemporarily protects minor:
  • Cuts
  • Scrapes
  • Burns
  • Temporarily protects and helps relieve chapped, chafed or cracked skin and lipsprotect chafed skin due to diaper rash and helps seal out wetness

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

  • For skin protectant use apply as needed
  • For diaper rash use:change wet and soiled diapers promptlycleanse the diaper area, and allow to dryapply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

Store between 20°C to 25 °C (68° to 77°F)

Inactive Ingredients

Cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

* Please review the disclaimer below.