NDC 78821-124 Phyto Clean Hand Sanitizer Lemon

Shcpc-014-17

NDC Product Code 78821-124

NDC 78821-124-17

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Phyto Clean Hand Sanitizer Lemon with NDC 78821-124 is a a human over the counter drug product labeled by Rhino Linings Corporation. The generic name of Phyto Clean Hand Sanitizer Lemon is shcpc-014-17. The product's dosage form is gel and is administered via topical form.

Labeler Name: Rhino Linings Corporation

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.

Phyto Clean Hand Sanitizer Lemon 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 70 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.

  • (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ALOE (UNII: V5VD430YW9)
  • FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)
  • (2-(((2-(2-AMINO-3-HYDROXY-2-(HYDROXYMETHYL)PROPOXY)-1-HYDROXYPROPYL)HYDROXYPHOSPHORYL)OXY)-1-HYDROXYPROPYL)PHOSPHONIC ACID (UNII: H24O03I2RP)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • PHOSPHORODITHIOIC ACID, O,O-DI-C1-14-ALKYL ESTERS (UNII: JZ1ZJL9173)
  • TRIETHANOLAMINE LAURATE (UNII: 9403LC9W1J)

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: Rhino Linings Corporation
Labeler Code: 78821
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: 12-11-2020 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.

Phyto Clean Hand Sanitizer Lemon 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

Ethyl Alcohol 70% v/v

Otc - Purpose

Hand Sanitizer

Indications & Usage

An antiseptic hand sanitizer for topical application.

Helps prevent infection and cross-contamination

Reduces transient microorganisms on intact skin.

Recommended for repeated use

Warnings

For external use only

Otc - When Using

Avoid contact with eyes.if contact with eyes occurs, flush with water.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develops and persists.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, seek prompt medical attention.

Dosage & Administration

Wet hand thoroughly with product and allow to dry without wiping

Storage And Handling

Flamable Keep away from open flame. Do not store above 110 F

Inactive Ingredient

Glycerin, Lemonal, C10-30 Acrylate Crosspolymer, Propanoic Acid, Propanediol, Hydroxyethylene Diamine,

C12-15-alkyl esters, Methyl Propane Diol, Aloe Vera Leaf Juice, Triethanolamine, And Deionized Water

* Please review the disclaimer below.