NDC 59448-204 Northside Hospital Bereavement
Alcohol And Sodium Monofluorophosphate
NDC Product 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.
NDC Code Structure
- 59448 - Asp Global, Llc
- 59448-204 - Northside Hospital Bereavement
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: 12-31-2021 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.
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
- Active Ingredient
- Purpose
- Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Inactive Ingredients
- Uses
- Warnings
- Otc - When Using
- Otc - Stop Use
- Other Information
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.