NDC 70873-001 Anti-bacterial Hand Sanitizer

Ethyl Alcohol

NDC Product Code 70873-001

NDC 70873-001-01

Package Description: 29.5 mL in 1 BOTTLE

NDC 70873-001-02

Package Description: 29.5 mL in 1 BOTTLE

NDC Product Information

Anti-bacterial Hand Sanitizer with NDC 70873-001 is a a human over the counter drug product labeled by Simply Clean,llc. The generic name of Anti-bacterial Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 581660.

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.

Anti-bacterial 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.


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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Simply Clean,llc
Labeler Code: 70873
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: 07-28-2016 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Anti-bacterial Hand Sanitizer Product Label Images

Anti-bacterial 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

Otc - Active Ingredient

Active Ingredient:
Ethyl Alcohol 62%

Otc - Purpose

Purpose:
Antimicrobial

Warnings

WARNING:

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
FOR EXTERNAL USE ONLY.DO NOT USE IN THE EYES.

Otc - Stop Use

DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP.

IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR OR PHYSICIAN.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Dosage & Administration

Directions:
Rub into hands until dry.

Inactive Ingredient

Water, Aloe barbadenis Leaf Juice, Glycerin,Propylene Glycol, Olive Oil PEG-7 Esters, Fragrance, Carbomer, Triethanolamine, FD&C Red NO.4, FD&C Yellow NO.5.

Storage And Handling

Other Information:
Store below 110 F.

Indications & Usage

KILLS MORE THAN 99.99% OF COMMON GERMS

* Please review the disclaimer below.