NDC 75115-467 Instant Hand Sanitizer Citrus

Alcohol

NDC Product Code 75115-467

NDC 75115-467-02

Package Description: 59 mL in 1 BOTTLE

NDC 75115-467-04

Package Description: 118 mL in 1 BOTTLE

NDC 75115-467-08

Package Description: 236 mL in 1 BOTTLE

NDC 75115-467-16

Package Description: 473 mL in 1 BOTTLE

NDC 75115-467-99

Package Description: 3785 mL in 1 BOTTLE

NDC Product Information

Instant Hand Sanitizer Citrus with NDC 75115-467 is a a human over the counter drug product labeled by Soapbox Soaps Llc. The generic name of Instant Hand Sanitizer Citrus is 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: 581662.

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.

Instant Hand Sanitizer Citrus 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Soapbox Soaps Llc
Labeler Code: 75115
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: 06-08-2020 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: 12-31-2022 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.

Instant Hand Sanitizer Citrus Product Label Images

Instant Hand Sanitizer Citrus 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

Uses

  • Hand sanitizer to help reduce bacteria
  • On the skin

Warnings

Flammable. Keep away from fire or flameFor external use only - hands.

Do Not Use

In or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop Use And Ask A Doctor

If skin irritation and redness or rash develops.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product in your palm to thoroughly cover your handsrub hands together briskly until drychildren under 6 years of age should be supervised when using this productnot recommended for infants

Other Information

  • Store at normal room temperature may discolor certain fabricsmay be harmful to wood finishes and plastics

Inactive Ingredients

Purified Water, Isopropyl Alcohol, Propylene Glycol, Fragrance, Aloe Barbadensis Leaf Juice (Decolorized), Carbomer, Glycerin, Aminomethyl Propanol, Isopropyl Myristate, Tocopheryl Acetate

Package Labeling

SBSOAPBOXHAND SANITIZER70% ALCOHOLBASED FORMULALIGHT CITRUS SCENTHELPS REDUCE PATHOGENIC GERMS ON HANDSWITH MOISTURIZERS& ALOE VERA8 FL OZ. (236 Ml)

* Please review the disclaimer below.