NDC 12745-850 Spectragenix Hand Sanitizer Antiseptic Hand Wash

Ethyl Alcohol

NDC Product Code 12745-850

NDC 12745-850-01

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC 12745-850-02

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 12745-850-03

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Spectragenix Hand Sanitizer Antiseptic Hand Wash with NDC 12745-850 is a a human over the counter drug product labeled by Medical Chemical Corporation. The generic name of Spectragenix Hand Sanitizer Antiseptic Hand Wash is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Medical Chemical Corporation

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.

Spectragenix Hand Sanitizer Antiseptic Hand Wash 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 55.34 g/100mL
  • DIAZOLIDINYL UREA .167 g/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.

  • SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • CETYL LACTATE (UNII: A7EVH2RK4O)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIISOPROPYLAMINE (UNII: BR9JLI40NO)
  • 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: Medical Chemical Corporation
Labeler Code: 12745
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: 10-23-2020 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.

Spectragenix Hand Sanitizer Antiseptic Hand Wash Product Label Images

Spectragenix Hand Sanitizer Antiseptic Hand Wash 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

Purpose

Germicide

Active Ingredients

Ethyl Alcohol 70% v/v

Inactive Ingredients

Purified water, Emollients (Laurel, Myristal and Cetyl Lactate,), Aloe Vera, Carbomer, Parabens, Diisopropylamine

Warnings

Warnings: Flammable, keep away from fire or flame.  For external use only.  Do no use in the eyes.  Discontinue use if irritation or redness develops.  Keep out of reach of children.  In case of ingestion contact poison control center immediately.

Danger: Highly flammable liqid and vapor. Keep away from heat, sparks, open flames and hot surfaces. No smoking. Keep container tightly closed. Use only non-sparking tools. Take precautions against static discharge. In case of fire, use fire extinguishers approved for alcohol fires. In case of ingestion contact a poison control center. Discontinue use if irritation or redness develops. Keep out of reach of children.

Directions

Spray about 5 g (1 tsp.) on to one hand and spread over both hands to the wrist. Rub into the skin until dry. Repeat.

Uses

Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes.

* Please review the disclaimer below.