NDC 79508-010 Doc Hygiene

Ethyl Alcohol

NDC Product Code 79508-010

NDC 79508-010-01

Package Description: 3 mL in 1 PACKET

NDC 79508-010-02

Package Description: 50 PACKET in 1 BOX > 3 mL in 1 PACKET (79508-010-01)

NDC Product Information

Doc Hygiene with NDC 79508-010 is a a human over the counter drug product labeled by Blue Flame Medical Llc. The generic name of Doc Hygiene is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Blue Flame Medical Llc

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.

Doc Hygiene 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

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: Blue Flame Medical Llc
Labeler Code: 79508
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: 07-08-2020 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.

Doc Hygiene Product Label Images

Doc Hygiene 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% v/v

Purpose

Antiseptic

Uses

  • For use when antibacterial soap and water are not available.Recommended for repeated use.Hand sanitizer to help reduce illness causing bacteria on the skin.

Warnings

  • For external use only. Do not use on open skin wounds.When using this product, keep out of or AWAY from eyes, ears, nose and mouth. In case of unwanted contact, rinse thoroughly with water.Stop use and seek help from a licensed doctor or medical professional if rash or irritation occurs as these may be signs of serious condition or illness.Do not swallow or ingest. If swallowed, seek medical help and contact a Poison Control Center immediately.Flammable. Keep away from sources of heat or fire.May be harmful to some fabrics, wood finishes, and plastics.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Do use on children less than 2 months of age. Children under 6 years of age should be supervised when using this product to avoid swallowing.

Directions

  • Open packet. Lightly squeeze the packet into the palm of your hand with enough product to cover both of your hands. Rub hands together, spread product over the backs of each hand, and in the between each finger.Children under 6 years of age should be supervised when using this product.

Other Information

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

Inactive Ingredients

  • Ethyl Alcohol 75%,Water(Aqua),Glycerin,Aloe barbadensis leaf extract,Tocopheryl Acetate(Vitamin E),Carbomer,Aminomethyl Propanol,PEG-40 Hydrogenated castor oil.

* Please review the disclaimer below.