NDC 78408-001 Hot Collection Instant Hand Sanitizer

Alcohol

NDC Product Code 78408-001

NDC 78408-001-01

Package Description: 30 mL in 1 BOTTLE

NDC 78408-001-02

Package Description: 60 mL in 1 BOTTLE

NDC 78408-001-03

Package Description: 100 mL in 1 BOTTLE

NDC 78408-001-04

Package Description: 500 mL in 1 BOTTLE

NDC 78408-001-05

Package Description: 1100 mL in 1 BOTTLE

NDC Product Information

Hot Collection Instant Hand Sanitizer with NDC 78408-001 is a a human over the counter drug product labeled by Jinhua Venice Cosmetic Co., Ltd. The generic name of Hot Collection Instant Hand Sanitizer is alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Jinhua Venice Cosmetic Co., Ltd

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Hot Collection Instant Hand Sanitizer 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 75 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

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: Jinhua Venice Cosmetic Co., Ltd
Labeler Code: 78408
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: 05-26-2020 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.

Hot Collection Instant Hand Sanitizer Product Label Images

Hot Collection Instant Hand Sanitizer 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

NA

Active Ingredient(S)

Ethyl Alcohol 75% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to decrease bacteria on the skin that could cause disease

Warnings

For external use only.Flammable. Keep away from heat and flame

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush with plenty of water and seek medical advice

Otc - Stop Use

Stop use and consult a doctor if irritation or redness occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center

Directions

Rub hands thoroughly with this product untill dryChildren younger than 6 should be supervised by an adult when using

Other Information

Store below 110F (43C)

Inactive Ingredients

Water, glycerin, carbomer, aminomethyl propanol, isopropyl myristate, tocopheryl acetate, aloe vera

* Please review the disclaimer below.