NDC 78806-600 Warrior Wipes Sanitizing Wipes

Ethyl Alcohol

NDC Product Code 78806-600

NDC 78806-600-30

Package Description: 90 PACKAGE in 1 CANISTER > 5 mL in 1 PACKAGE

NDC 78806-600-50

Package Description: 270 PACKAGE in 1 CANISTER > 5 mL in 1 PACKAGE

NDC 78806-600-80

Package Description: 350 PACKAGE in 1 CANISTER > 5 mL in 1 PACKAGE

NDC Product Information

Warrior Wipes Sanitizing Wipes with NDC 78806-600 is a a human over the counter drug product labeled by All Clean Natural Ltd. The generic name of Warrior Wipes Sanitizing Wipes is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: All Clean Natural Ltd

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Warrior Wipes Sanitizing Wipes 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 80 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)

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: All Clean Natural Ltd
Labeler Code: 78806
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: 01-04-2021 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: 12-31-2021 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.

Warrior Wipes Sanitizing Wipes 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 Ingredient

Ethyl Alcohol 80% V/V

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that can potentially 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- On children less than 2 months of age- On open skin woundsStop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Purified water, Glycerin, Hydrogen Peroxide

Other

FRAGRANCE FREE*Close Cap After Use*NPN 80103441

NDC 78806-600-XX
Manufactured By:

All Clean Natural

5310 1 St SW

Calgary, AB T2H 0C8
allcleannatural.comDIRECTIONS: For first use, remove lid. Thread wipe from center of roll through dispensing hole in the lid and pull wipe up and slightly downwards to the side. Snap lid securely shut. Remove cap and pull wipe to the side to dispense. Keep cap closed between uses to prevent moisture loss. Wipe hands, discard.
WARNING: For external use only. Do not ingest. If ingested, drink plenty of water and contact poison control. Avoid contact with eyes. If contact occurs, flush thoroughly with water. If skin irritation occurs, discontinue use. Keep out of reach of children and pets. Children must be under adult supervision while using this product. This product contains 80% ethyl alcohol and may damage certain surfaces. Always test in an inconspicuous area first to ensure the surface will not be damaged. Not recommended for varnished, painted, or coated surfaces where other solvents may damage the finish. WHO Recommended Formula.

* Please review the disclaimer below.