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NDC 81470-002 Shield And Heal Lip Balm

Menthol Kit Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 81470-002?
  4. Shield And Heal Lip Balm Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
81470-002
Proprietary Name:
Shield And Heal Lip Balm
Non-Proprietary Name: [1]
Menthol
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Shield And Heal Inc.
    Labeler Code:
    81470
    Product Label ID:
    ba5eed7d-211e-25ef-e053-2995a90a159c
    FDA Application Number: [6]
    part348
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    02-15-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 81470-002-01

    Package Description: 1 KIT in 1 KIT * 2 TUBE in 1 KIT / 4.25 g in 1 TUBE * 2 TUBE in 1 KIT / 4.25 g in 1 TUBE

    Product Details

    What is NDC 81470-002?

    The NDC code 81470-002 is assigned by the FDA to the product Shield And Heal Lip Balm which is a human over the counter drug product labeled by Shield And Heal Inc.. The generic name of Shield And Heal Lip Balm is menthol. The product's dosage form is kit and is administered via topical form. The product is distributed in a single package with assigned NDC code 81470-002-01 1 kit in 1 kit * 2 tube in 1 kit / 4.25 g in 1 tube * 2 tube in 1 kit / 4.25 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Shield And Heal Lip Balm?

    Children under 2 years of age: consult a doctor.adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

    Which are Shield And Heal Lip Balm UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Shield And Heal Lip Balm Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".