NDC 81451-006 Hand Sanitizer Tobacco Leather

Isopopyl Alcohol 70% V/v

NDC Product Code 81451-006

NDC 81451-006-01

Package Description: 40 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Hand Sanitizer Tobacco Leather with NDC 81451-006 is a a human over the counter drug product labeled by Pame Eco Tech. The generic name of Hand Sanitizer Tobacco Leather is isopopyl alcohol 70% v/v. The product's dosage form is gel and is administered via topical form.

Labeler Name: Pame Eco Tech

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.

Hand Sanitizer Tobacco Leather 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.

  • ISOPROPYL ALCOHOL 70 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.

  • WATER (UNII: 059QF0KO0R)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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.

Product Labeler Information

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

Labeler Name: Pame Eco Tech
Labeler Code: 81451
FDA Application Number: part333A 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: 01-25-2021 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.

Hand Sanitizer Tobacco Leather Product Label Images

Hand Sanitizer Tobacco Leather 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

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Uses:

Effective indestroying(harmful) bacteria to provide antseptic cleansing recommeded for repeated use .

Warnings

For external use only. Flammable . Keep away from fire or flame

Otc - Do Not Use

On children less than 2 months of ageOn open skin wounds

Otc - Stop Use

Stop use and ask a doctor if irritation or rash develops and lasts for more than 72 hours.

Otc - When Using

  • Avoid contact with eyesIf contact occureRinse thoroughly with water.

Storage And Handling

Do not store above 105F(41 C)

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

Inactive Ingredient

Water, Ricinus Communis Seed oil, Acrylates copolymer, Glycerin,Aloe Vera Juice, Isopropyl Myristate, Tococpheryl Acetate,TriethanolamineParfum

Dosage & Administration

  • Rub thoroughly into hands for at least 30 seconds.Allow to dryFor children under 6, use only under adult supervision.Not recommended for infants.

Otc - Purpose

Antiseptic , Hand Sanitizer

* Please review the disclaimer below.