NDC 58503-043 Xtracare Hand Sanitizer Moisturize With Vitamin E

Ethyl Alcohol

NDC Product Code 58503-043

NDC CODE: 58503-043

Proprietary Name: Xtracare Hand Sanitizer Moisturize With Vitamin E 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: Ethyl Alcohol 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.

NDC Code Structure

  • 58503 - China Ningbo Shangge Cosmetic Technology Corp

NDC 58503-043-01

Package Description: 236 g in 1 BOTTLE

NDC Product Information

Xtracare Hand Sanitizer Moisturize With Vitamin E with NDC 58503-043 is a a human over the counter drug product labeled by China Ningbo Shangge Cosmetic Technology Corp. The generic name of Xtracare Hand Sanitizer Moisturize With Vitamin E is ethyl alcohol. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 581660.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Xtracare Hand Sanitizer Moisturize With Vitamin E 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.

  • WATER (UNII: 059QF0KO0R)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: China Ningbo Shangge Cosmetic Technology Corp
Labeler Code: 58503
FDA Application Number: part333E 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 01-24-2014 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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Xtracare Hand Sanitizer Moisturize With Vitamin E Product Label Images

Xtracare Hand Sanitizer Moisturize With Vitamin E 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                                 PurposeEthyl Alcohol 62.0% ....................... Antimicrobial

Otc - Purpose

  • Usesfor handwashing to decrease bacteria on the skinrecommended for repeated use

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.

Indications & Usage

XtraCare® Hand Sanitizer AntibacterialKills 99% of GermsMoisturize with Vitamin E8 Fl Oz (236 mL)

Warnings

WarningsFor external use only.Flammable, keep away from heat and flame.Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Dosage & Administration

  • Directionswet hands thoroughly with productbriskly rub hands together until drysupervise children under 6 years of age in the use of this product

Inactive Ingredient

Inactive Ingredients:water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate.

Other Safety Information

  • Other Informationstore at 20oC to 25oC (68o to 77oF)may discolor certain fabricsQuestions/Comments? 1-855-345-5575DISTRIBUTED BY:REJOICE INTERNATIONAL INCNORTHVILLE, MI 48168, USAMADE IN CHINA

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