NDC 59448-204 Northside Hospital Bereavement

Alcohol And Sodium Monofluorophosphate

  1. Labeler Index
  2. Asp Global, Llc
  3. NDC: 59448-204 Northside Hospital Bereavement

NDC Product Code 59448-204

NDC CODE: 59448-204

Proprietary Name: Northside Hospital Bereavement 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 And Sodium Monofluorophosphate 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.

Product Characteristics

Color(s):
WHITE (C48325)
YELLOW (C48330)
GREEN (C48329)
BLUE (C48333)
Flavor(s):
MINT (C73404)

NDC Code Structure

  • 59448 - Asp Global, Llc

NDC 59448-204-00

Package Description: 1 KIT in 1 BAG * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-001-02)

NDC Product Information

Northside Hospital Bereavement with NDC 59448-204 is a a human over the counter drug product labeled by Asp Global, Llc. The generic name of Northside Hospital Bereavement is alcohol and sodium monofluorophosphate. The product's dosage form is kit and is administered via form.

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: 10-19-2017 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Northside Hospital Bereavement Product Label Images

Northside Hospital Bereavement 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

Other

Colgate® Anticavity ToothpasteDrug Facts

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

Instant Hand AntisepticDrug Facts

Distributed by:Anatomy Supply PartnersAtlanta, GA 30331-USA

Active Ingredient

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

Ethyl Alcohol 62%

Purpose

Anticavity

Antiseptic

Use

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.

Directions

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, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene

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

Uses

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

Warnings

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.