NDC 78503-200 Safetymax Alcohol Wipes

Ethyl Alcohol

NDC Product Code 78503-200

NDC 78503-200-01

Package Description: 100 PACKAGE in 1 CANISTER > 4.725 mL in 1 PACKAGE

NDC Product Information

Safetymax Alcohol Wipes with NDC 78503-200 is a a human over the counter drug product labeled by Safetymax Corporation. The generic name of Safetymax Alcohol Wipes is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Safetymax Corporation

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.

Safetymax Alcohol 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 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.

  • WATER (UNII: 059QF0KO0R)

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: Safetymax Corporation
Labeler Code: 78503
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: 09-01-2020 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’.

* Please review the disclaimer below.

Safetymax Alcohol Wipes Product Label Images

Safetymax Alcohol 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 75.0%

Purpose

Antiseptic

Uses

• To help reduce bacteria on the skin and help prevent cross contamination.

Warnings

For external use only. Flammable. Keep away from heat or flame.Do not use• in children less than 2 months of age• on open skin woundsWhen using this product do not use in or near the eyes. In case of contact, 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 unless under adult supervision. If swallowed, get medical help or contact a poison control center immediately.

Directions

• Open flip top when in use, pull out one wipe at a time for use. Close after use to prevent wipes from drying out

Other Information

• Store in a well-ventilated place

Inactive Ingredients:

Pure water

Other

Emergency Preparedness SolutionsANTI-BACTERIAL WIPESKILLS MORE THAN 99.99% OF GERMS75% ETHYL ALCOHOLExternal UseDistributed by:SafetyMax CorporationSan Francisco, CA 94124B.C.: 20135001MADE IN PRCPOWERFUL ANTIBACTERIAL WIPES• Kills 99.99% bacterial in seconds• Powerful antibacterial wipes• Cleans and disinfects• Soft and extra moist• Gentle on hands• Alcohol formula• Bleach freeTO OPEN PACKAGE:Pull out wipe from center of roll.Next sheet pops up automatically.Close lid to retain moistureExpiration Date: Spray codeShelf Life: 24 months HomeOfficeSchoolTravelToyCarToiletSportsShoppingPhone

* Please review the disclaimer below.