NDC 80382-001 Hydrating Hand Saintizer

Ethyl Alcohol

NDC Product Code 80382-001

NDC 80382-001-30

Package Description: 3780 mL in 1 BOTTLE, PUMP

NDC Product Information

Hydrating Hand Saintizer with NDC 80382-001 is a a human over the counter drug product labeled by Natural Distributions Ltd. O/a Purple Frog Products Suite. The generic name of Hydrating Hand Saintizer is ethyl alcohol. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Natural Distributions Ltd. O/a Purple Frog Products Suite

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

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.

Hydrating Hand Saintizer 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/1000mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GRAPEFRUIT OIL (UNII: YR377U58W9)

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.
  • 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: Natural Distributions Ltd. O/a Purple Frog Products Suite
Labeler Code: 80382
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: 09-20-2020 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.

Hydrating Hand Saintizer Product Label Images

Hydrating Hand Saintizer 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

Otc - Active Ingredient

Ethyl Alcohol 70%

Otc - Purpose

Purpose -Antiseptic Skin cleanser

Indications & Usage

  • UseAntiseptic Skin cleanser

Warnings

WarningsKeep away from open flame & sources of heat.For extenal use only.

Otc - Keep Out Of Reach Of Children

Keep out of childrenIf accidently swallowed, call a posion control center or get medical help right away.

User Safety Warnings

Do not get into eyesIf contact occurs, rinse thoroughly with water

Dosage & Administration

  • Children,adolescents and adults 2 years and over.for occasional and personal domestic usesupervise children when they use this product.Place enough product on your plam to thoroughly cover your hands.rub thoroughly into hands for at least 30 secondsAllow to dry.

Other Safety Information

  • Other InformationMay discolor certain fabrics or surfacesdo not store above 110 F ( 43 C)

Inactive Ingredient

Distilled Water, Vegetable Glycerin, PEG 10 Dimethicone, Grapefruit Essential Oil Blend, Aloe Barbadensis Leaf Juice, Denatonium Benzoate.

* Please review the disclaimer below.