NDC 59448-600 Sarasota Memorial Amenity

Alcohol And Sodium Monofluorophosphate

NDC Product Code 59448-600

NDC 59448-600-00

Package Description: 30 BAG in 1 BOX > 1 KIT in 1 BAG * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-004-01)

NDC Product Information

Sarasota Memorial Amenity with NDC 59448-600 is a a human over the counter drug product labeled by Asp Global, Llc. The generic name of Sarasota Memorial Amenity is alcohol and sodium monofluorophosphate. The product's dosage form is kit and is administered via form.

Labeler Name: Asp Global, Llc

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

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

Labeler Name: Asp Global, Llc
Labeler Code: 59448
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: 10-08-2019 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: 12-31-2020 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.

Sarasota Memorial Amenity 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


Colgate® Anticavity ToothpasteDrug Facts

Manufactured by:COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand.

Instant Hand AntisepticDrug Facts

Distributed by:ASP Global, LLC 3450 Atlanta Industrial ParkwayAtlanta, GA 30331

Active Ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Ethyl Alcohol 62%





Helps protect against cavities

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help.


Adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician

Not recommended for infants.Wet hands thoroughly with product and allow to dry without wiping.Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.


For hand washing to decrease bacteria on the skin.Recommended for repeated use.


Flammable. Keep away from fire or flame.For external use only.Avoid contact with broken skin.

Otc - When Using

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Other Information

Do not store above 110°F. May discolor some fabrics.

* Please review the disclaimer below.