NDC 71927-002 Hand Sanitizer

NDC Product Code 71927-002

NDC 71927-002-01

Package Description: 37 mL in 1 BOTTLE, PLASTIC

NDC 71927-002-02

Package Description: 37 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Hand Sanitizer with NDC 71927-002 is a product labeled by Orazen Inc. The generic name of Hand Sanitizer is . The product's dosage form is and is administered via form.

Labeler Name: Orazen Inc

Dosage Form: -

Product Type: 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.

Hand Sanitizer 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.

  • ALCOHOL 62 mL/100mL

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.

  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • TROLAMINE (UNII: 9O3K93S3TK)

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.
  • 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: Orazen Inc
Labeler Code: 71927
Start Marketing Date: 07-06-2018 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: 12-31-2019 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: I 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.

Hand Sanitizer Product Label Images

Hand Sanitizer 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:
Ethyl alcohol 62%

Otc - Purpose

PurposeAntiseptic

Warnings

WarningsFor external use only: handsFlammable. Keep away from heat and flame.

Otc - Stop Use

  • Stop use and ask a doctor ifirritation or redness developscondition persists for more that 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Dosage & Administration

  • Directionswet hands thoroughly with product and allow to dry without wipingfor children under 6, ues only under adult supervision not recommended for infants

Inactive Ingredient

Inactive ingredientswater, glycerin, propylene glycol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf juice, maltodextrin

Other Safety Information

  • Other Informationdo not store above 105Fmay discolor some fabrics harmful to wood finishes and plastics

Indications & Usage

Uses to decrease bacteria on the skin
that could cause disease. recommended for repeated use

Otc - When Using

  • When using this productkeep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skindo not inhale or ingest

* Please review the disclaimer below.