NDC 79443-898 Viper Hand Sanitizer

Alcohol

NDC Product Code 79443-898

NDC 79443-898-01

Package Description: 3.78 L in 1 BOTTLE

NDC Product Information

Viper Hand Sanitizer with NDC 79443-898 is a a human over the counter drug product labeled by Rtx Scientific, Incorporated. The generic name of Viper Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Rtx Scientific, Incorporated

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.

Viper 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 .7 L/L

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Rtx Scientific, Incorporated
Labeler Code: 79443
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: 07-01-2020 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 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’.

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Viper Hand Sanitizer Product Label Images

Viper 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 ingredientAlcohol 70%

Otc - Purpose

PurposeAntiseptic

Indications & Usage

  • Useshand sanitizer to decrease bacteria on the skinrecommended for repeated usefor use when soap and water are not available

Warnings

WarningFlammable liquid and vapor. Can cause serious eye irritation.Keep container tightly closed. Keep out of reach of children.First Aid: If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical attention immediately. If swallowed: Call a Poison center or doctor if you feel unwell.When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Dosage & Administration

DirectionsPlace enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years when using this product to avoid swallowing.

Storage And Handling

Storage and Disposal: Store in cool/well-ventilated place. Dispose of contents and container according to the local, city, state and federal regulations.

Inactive Ingredient

Inactive ingredients: water, glycerin, polyacrylic acid polymer, fragrance, and aloe vera.

Other

Kills 99.99% of GermsLaboratory data demonstrates that 60% ethanol and 70% isopropanol, the active ingredients in CDC-recommended alcohol-based hand sanitizers, inactivates viruses that are genetically related to, and with similar physical properties as, the 2019-nCoV.FDA # 6256989801Manufactured for: Refrigeration Technologies,1111 N. Armando St., Anaheim CA 92806 • (714) 238-9207Emergency Contact: Chemtel (813) 284-0573For ingredient information visit: www.refrigtech.com

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