NDC 78080-002 Babyliss Pro Protect Hand Sanitizer

Alcohol

NDC Product Code 78080-002

NDC 78080-002-00

Package Description: 12 BOTTLE in 1 BOX > 488 mL in 1 BOTTLE

NDC Product Information

Babyliss Pro Protect Hand Sanitizer with NDC 78080-002 is a a human over the counter drug product labeled by Makmac Inc. The generic name of Babyliss Pro Protect Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Makmac Inc

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.

Babyliss Pro Protect 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 mL/mL

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)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Makmac Inc
Labeler Code: 78080
FDA Application Number: part333E 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: 09-25-2020 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.

Babyliss Pro Protect Hand Sanitizer Product Label Images

Babyliss Pro Protect 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

Active Ingredient

Ethyl Alcohol 70% V/V

Purpose

Antiseptic

Use

Antibacterial hand sanitizing gel to help kill bacteria and germs as antiseptic on the skin. For use when soap and water are not available.

Warnings

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

When Using This Product

Keep out of eyes and mouth. In case of contact with eyes, immediately rinse eyes thoroughly with water.

Stop Use And Ask Doctor If

Irritation, rash or allergy 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.

Directions

Apply. Put enough product on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds. Recommended for repeated use. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 59-86°F (15-30°C)


Avoid freezing and excessive heat above 104°F (40°C)

Inactive Ingredients

Deionized Water. Carbomer. Panthenol. DMDM Hydantoin. Disodium EDTA. Triethanolamine.

* Please review the disclaimer below.