NDC 73812-003 Clean To Clean Hand Sanitizer

Hand Sanitizer

NDC Product Code 73812-003

NDC 73812-003-02

Package Description: 100 POUCH in 1 BOX > 2 mL in 1 POUCH (73812-003-03)

NDC Product Information

Clean To Clean Hand Sanitizer with NDC 73812-003 is a a human over the counter drug product labeled by Ltp Global. The generic name of Clean To Clean Hand Sanitizer is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ltp Global

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.

Clean To Clean 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.

  • ALCOHOL 62 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.

  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • WATER (UNII: 059QF0KO0R)
  • PANTHENOL (UNII: WV9CM0O67Z)

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: Ltp Global
Labeler Code: 73812
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: 05-29-2020 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.

Clean To Clean Hand Sanitizer Product Label Images

Clean To Clean 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

Active Ingredient(S)

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use

  • To decrease bacteria on the skin that could cause disease

Warnings

For external use only : handsFlammable. Keep away from heat or flame.

Otc - When Using

  • When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.avoid contact with broken skindo not inhale or ingest

Otc - Stop Use

  • Stop use and ask a doctor ifirritation and rash occurs. These may be signs of serious condition

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Put enough product in your palm to cover hands and rub hands together briskly until dryChildren under 6 years should be supervised when using this product

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)Do not use on children under two months of age.

Inactive Ingredients

Water, Carbomer, Tromethamin, Glycerin, Propylene Glycol, Panthenol, Aloe Barbadensis Leaf, Sodium Hyalunate, Tocopheryl Acetate

* Please review the disclaimer below.