NDC 78974-0001 Rrub Rinse Free Hand Wash-alcohol Version

Alcohol

NDC Product Code 78974-0001

NDC 78974-0001-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC 78974-0001-2

Package Description: 400 mL in 1 BAG

NDC Product Information

Rrub Rinse Free Hand Wash-alcohol Version with NDC 78974-0001 is a a human over the counter drug product labeled by Champs Industrial Pte Ltd. The generic name of Rrub Rinse Free Hand Wash-alcohol Version is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Champs Industrial Pte Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Rrub Rinse Free Hand Wash-alcohol Version 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 75 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.

  • ALPHA CELLULOSE (UNII: I355QGZ19A)
  • CITRIC ACID, 1-STEARYL ESTER (UNII: E945AJ51FA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)

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: Champs Industrial Pte Ltd
Labeler Code: 78974
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: 07-15-2020 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’.

* Please review the disclaimer below.

Rrub Rinse Free Hand Wash-alcohol Version 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

Other

  • This is a hand sanitizer manufactured according to the
  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
  • The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.Glycerol (1.45% v/v).MET® Microbe Encapsulation Technology ingredients.Sterile distilled water or boiled cold water.The MET® Microbe Encapsulation Technology ingredients help to physically remove the dead bacteria killed by actives ingredients. Thus the effectiveness is enhanced than sanitizing only.

Active Ingredient(S)

Alcohol version: Alcohol 75% v/v. Purpose: Antisepticnon-alcohol version: Benzalkonium chloride, cetyl Pyridinium chloride. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

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.


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

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.

Directions

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

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Glycerin, purified water USP, MET® Microbe Encapsulation Technology ingredients.

Recent Major Changes

Rrub Rinse-free Hand Wash Alcohol version 30 mL NDC: 78974-0001Two images have been uploaded with the name of "rrub Alcohol version" and "rrub alcohol refill" respectively.rrub Rinse-free Hand Wash Non-alcohol version 30 mL NDC: 78974-0002Two images have been uploaded with the name of "rrub nonAlcohol version" and "rrub nonalcohol refill" respectively.

* Please review the disclaimer below.