NDC 80424-009 Sweet Sugar Fantasy Hand Sanitizer Antibacterial

Alcohol

NDC Product Code 80424-009

NDC 80424-009-01

Package Description: 3 BOTTLE in 1 BLISTER PACK > 30 mL in 1 BOTTLE (80424-009-30)

NDC Product Information

Sweet Sugar Fantasy Hand Sanitizer Antibacterial with NDC 80424-009 is a a human over the counter drug product labeled by Core Home. The generic name of Sweet Sugar Fantasy Hand Sanitizer Antibacterial is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Core Home

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.

Sweet Sugar Fantasy Hand Sanitizer Antibacterial 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 63 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • WATER (UNII: 059QF0KO0R)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Core Home
Labeler Code: 80424
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: 05-05-2021 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.

Sweet Sugar Fantasy Hand Sanitizer Antibacterial Product Label Images

Sweet Sugar Fantasy Hand Sanitizer Antibacterial 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

Alcohol 63%

Purpose

Antiseptic

Uses

■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use

Warnings

For external use onlyFlammable,
keep away from fire and flameDoes not contain grain alcohol, do not drink. If taken internally will produce gastric distrubances.

When Using This Product

■ Avoid the eyes and mucoous membranes■ In the case of eyes or mucous membranes contacr, rinse area thoroughly with water

Stop Use And Ask A Doctor If

■ Condition worsens■ Redness or irritation develops■ Condition persists for more than 3 days

Keep Out Of Reach Of Children

■ If swallowed, contact a doctor or Poison Control Center immediately.

Directions

■ Rub dime sized amount between hands until dry.■ Supervise children in the use of this product.■ In the case of eye contact, rinse eyes thoroughly with water.

Other Information

■ Store below 105ºF■ May discolor some fabrics.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Fragrance, PEG-40 Hydrogenated Castor Oil, Water, Yellow 5

Questions?

■ 1-800-278-9218

* Please review the disclaimer below.