NDC 70393-456 Caretouch Alcohol-free Foaming Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 70393-456

NDC Code: 70393-456

Proprietary Name: Caretouch Alcohol-free Foaming Hand Sanitizer Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 70393 - Future Diagnostics Llc
    • 70393-456 - Caretouch Alcohol-free Foaming Hand Sanitizer

NDC 70393-456-04

Package Description: 4 BOTTLE, PLASTIC in 1 BAG > 300 mL in 1 BOTTLE, PLASTIC (70393-456-25)

NDC 70393-456-25

Package Description: 300 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Caretouch Alcohol-free Foaming Hand Sanitizer with NDC 70393-456 is a a human over the counter drug product labeled by Future Diagnostics Llc. The generic name of Caretouch Alcohol-free Foaming Hand Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Future Diagnostics Llc

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 Additional informationCallout TooltipWhat 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.


Caretouch Alcohol-free Foaming Hand Sanitizer Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM CHLORIDE 1 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • BETAINE (UNII: 3SCV180C9W)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Future Diagnostics Llc
Labeler Code: 70393
FDA Application Number: part333A Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Caretouch Alcohol-free Foaming Hand Sanitizer Product Label Images

Caretouch Alcohol-free Foaming 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

Benzalkonium chloride 0.1%

Purpose

Antibacterial

Uses

• For hand washing to decrease bacteria on the skin.

Warnings

For external use only.When using this product if eye contact occurs, rinse thoroughly with water.Stop use and ask a doctor if irritation or redness develops and persist for more than 72 hours.

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

• Apply small amount of foam to hands as desired, allow drying without wiping.

Storage

• Store at room temperature• Avoid direct sunlight.

Inactive Ingredient

Water, Betaine Anhydrous, Diazolidinyl urea, Phenoxyethanol, Palmitamidopropyltrimonium Chloride, Propylene Glycol, Sodium Citrate

* Please review the disclaimer below.

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