NDC 74511-002 Pure Passion Hand Sanitizer Juicy Watermelon

Alcohol

NDC Product Code 74511-002

NDC CODE: 74511-002

Proprietary Name: Pure Passion Hand Sanitizer Juicy Watermelon 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 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

  • 74511 - Xiamen Meidai Cross-border E-commerce Co., Ltd.
    • 74511-002 - Pure Passion Hand Sanitizer Juicy Watermelon

NDC 74511-002-01

Package Description: 236 mL in 1 BOTTLE

NDC Product Information

Pure Passion Hand Sanitizer Juicy Watermelon with NDC 74511-002 is a a human over the counter drug product labeled by Xiamen Meidai Cross-border E-commerce Co., Ltd.. The generic name of Pure Passion Hand Sanitizer Juicy Watermelon is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Xiamen Meidai Cross-border E-commerce Co., Ltd.

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.

Pure Passion Hand Sanitizer Juicy Watermelon 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/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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER 934 (UNII: Z135WT9208)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)

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: Xiamen Meidai Cross-border E-commerce Co., Ltd.
Labeler Code: 74511
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: 05-04-2020 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.

Pure Passion Hand Sanitizer Juicy Watermelon Product Label Images

Pure Passion Hand Sanitizer Juicy Watermelon 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

Active ingredient(s)                                       PurposeEthyl Alcohol  70%       ...............                 Antiseptic

Otc - Purpose

  • Hand sanitizer to help decrease bacteria on the skin.

Otc - Keep Out Of Reach Of Children

Children under 6, use only under adult supervision. Not recommended for infants.if swallowed, seek professional assistance or contact a Poison Control Center.

Indications & Usage

Place enough product in your palm to thoroughly spread on both hands and rub into skin until dry.

Warnings

For external use only: handsFlammable. Keep away from fire or flame.When using this product, avoid contact with eyes. In case of contact, flush eyes thoroughly with water. Avoid contact with broken skin.Stop and consult a doctor if irritation or redness develop. Condition persist for more than 72 hours.

Dosage & Administration

  • Other information:Do not store above 105℉May discolr some fabricsHarmful to wood finishes and plastics.

Inactive Ingredient

Water (Aqua), Glycerin, carbomer, Triethanolamine, Aloe Barbadensis gel Extract, fragrance (Parfum), FD&C Red No. 4

* Please review the disclaimer below.