NDC 43553-3256 Sensi Care Protective Barrier

Petrolatum, Zinc Oxide

NDC Product Code 43553-3256

NDC CODE: 43553-3256

Proprietary Name: Sensi Care Protective Barrier 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: Petrolatum, Zinc Oxide 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 43553 - Convatec Inc.

NDC 43553-3256-4

Package Description: 113 g in 1 TUBE

NDC Product Information

Sensi Care Protective Barrier with NDC 43553-3256 is a a human over the counter drug product labeled by Convatec Inc.. The generic name of Sensi Care Protective Barrier is petrolatum, zinc oxide. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Sensi Care Protective Barrier 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.

  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Convatec Inc.
Labeler Code: 43553
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: 01-05-2000 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 07-17-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Sensi Care Protective Barrier Product Label Images

Sensi Care Protective Barrier 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

Petrolatum 49%Zinc Oxide 15%

Purpose

Skin ProtectantSkin Protectant

Uses

  • Temporarily protects and helps relieve chapped or cracked skin and lips.Helps treat and prevent diaper rash.Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only.

Do Not Use On

  • Deep or puncture woundsanimal bitesserious burns.

When Using This Product

Do not get into eyes.

Stop Use And Ask Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or consult a Poison Control Center right away.

Directions

  • For skin protectionApply as needed.For diaper rashChange wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.Apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Other Information

Store at 15





oC - 30





oC (59





oF - 86





oF).

Inactive Ingredients

Carboxymethylcellulose Sodium, Water, Stearic Acid, Glycerin, Cetyl Dimethicone Copolyol, Polyglyceryl-4 Isostearate, Hexyl Laurate, Phenoxyethanol.

* Please review the disclaimer below.