NDC 74810-722 Clean Revolution

Hand Sanitizer

NDC Product Code 74810-722

NDC 74810-722-03

Package Description: 100 g in 1 BOTTLE, PLASTIC

NDC 74810-722-04

Package Description: 100 g in 1 BOTTLE, PUMP

NDC Product Information

Clean Revolution with NDC 74810-722 is a a human over the counter drug product labeled by Replenish Bottling Llc. The generic name of Clean Revolution is hand sanitizer. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Replenish Bottling Llc

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.

Clean Revolution 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 65.3 g/100g

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.

  • PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)

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: Replenish Bottling Llc
Labeler Code: 74810
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: 07-07-2020 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.

Clean Revolution 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

Active Ingredients.... Purpose

Ethyl Alcohol (70% v/v)..... Antiseptic

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeat use.

Warnings

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

• Keep out of reach of children.

When using, keep out of eyes. In case of contact, rinse eyes thoroughly with water.

• Avoid contact with broken skin. Stop use and consult a doctor if irritation or redness appears and lasts.

Avoid contact with broken skin. Stop use and consult a doctor if irritation or redness appears and lasts.

• Do not inhale or ingest.■ For children under 6, use only under adult supervision .■ Do not use in children less than 2 years of age.

■ Only use with dispensers and containers that have been cleaned, rinsed and are empty.

Directions

1. Remove foil seal under cap.2. For best results , pour into Clean Revolution® Refillable Foaming Bottle. To create foam, product must be dispensed from a foaming pump. Product can also be dispensed in a liquid consistency using a standard pump or spray bottle. Never mix this product with other household ingredients or pour into a bottle that previously contained other chemicals.3. Apply sanitizer to palm. Rub the product over the surfaces of both hands until your hands are dry.

Other Information

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

Inactive Ingredients

Deionized Water (Aqua) , Glycerin, PEG-10 Acrylate/ Perfluorohexylethyl Acrylate Copolymer (and) Perflurohexylethyl Alcohol, Coco-glucoside, Bis-Peg-12 Dimethicone, Fragrance

* Please review the disclaimer below.