NDC 54860-344 Smart Care Spring Water Hand Sanitizer 500ml 01


NDC Product Code 54860-344

NDC CODE: 54860-344

Proprietary Name: Smart Care Spring Water Hand Sanitizer 500ml 01 What 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: Alcohol What 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.

NDC Code Structure

  • 54860 - Shenzhen Lantern Scicence Co.,ltd.
    • 54860-344 - Smart Care Spring Water Hand Sanitizer 500ml

NDC 54860-344-01

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Smart Care Spring Water Hand Sanitizer 500ml 01 with NDC 54860-344 is a a human over the counter drug product labeled by Shenzhen Lantern Scicence Co.,ltd.. The generic name of Smart Care Spring Water Hand Sanitizer 500ml 01 is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Shenzhen Lantern Scicence Co.,ltd.

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.

Smart Care Spring Water Hand Sanitizer 500ml 01 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.

  • WATER (UNII: 059QF0KO0R)
  • CARBOMER 940 (UNII: 4Q93RCW27E)

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: Shenzhen Lantern Scicence Co.,ltd.
Labeler Code: 54860
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: 12-30-2020 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.

Smart Care Spring Water Hand Sanitizer 500ml 01 Product Label Images

Smart Care Spring Water Hand Sanitizer 500ml 01 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

Active Ingredient PurposeEthyl Alcohol 70%V/V Antiseptic


Health care personel hand rub to help reduce bacteria that potentially can cause disease.

To help reduce bacteria and germs on the skin.


For external use only;handsFlammable,keep away from fire or flame.

Warnings And Precautions

For external use only.Flammable, keep away from heat and flame.

Otc - Stop Use

Discontinue if skin becomes irritated and ask a doctor .

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poson control center immediately.

Keep Out Of Reach Of Children

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

Dosage & Administration

Recommended for repeated use.use anywhere without water.


Put a thumbnail size amount in your palm and rub your hands together briskly until dry.Children under 6 years of age should be supervised when using this product.Not recommended for infants.

Otc - Do Not Use

When using this productkeep out of eyes. In case of contact with eyes, flush thoroughly with water.Do not inhale or ingest.Avoid contact with broken skin.

Other Information

Do not store above 105F.May discolor some fabrics. Harmful to wood finishes and plastics.

Do not store above 100℉(38℃)May discolor some fabricsHarmful to wood finishes and plastics.

Inactive Ingredients

Alcohol,Aqua,Isopropyl Alcohol,Glycerin,Carbomer,Aminomethyl Propanol,Parfum,Propylene Glycol,Isopropyl Myristate,Aloe Barbadensis Leaf Water,Tocopheryl Acetate.

When Using This Product

Keep out of eyes,ears,and mouth.In case of contact with eyes,flush thoroughly with water.avoid contact with broken skin.do not inhale or ingest.

* Please review the disclaimer below.