NDC 55533-520 Healthy Hands Aloe Instant Hand Antibacterial

Alcohol

NDC Product Code 55533-520

NDC CODE: 55533-520

Proprietary Name: Healthy Hands Aloe Instant Hand Antibacterial 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.

Product Characteristics

Color(s):
GREEN (C48329)

NDC Code Structure

NDC 55533-520-25

Package Description: 532 mL in 1 BOTTLE, PUMP

NDC 55533-520-26

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Healthy Hands Aloe Instant Hand Antibacterial with NDC 55533-520 is a a human over the counter drug product labeled by Nch Corporation. The generic name of Healthy Hands Aloe Instant Hand Antibacterial is alcohol. The product's dosage form is soap and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 581660.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Healthy Hands Aloe Instant Hand 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.


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)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • DIISOPROPYLAMINE (UNII: BR9JLI40NO)

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: Nch Corporation
Labeler Code: 55533
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: 11-14-2014 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 - 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.

Healthy Hands Aloe Instant Hand Antibacterial Product Label Images

Healthy Hands Aloe Instant Hand 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

Drug Facts Active Ingredient

Ethyl Alcohol 62 % w/w

Purpose

Antimicrobial

Keep Out Of Reach Of Children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Uses

 to sanitize hands without requiring water or a rinse


 kills 99.9% of most common bacteria in 15 seconds

Warnings Flammable For External Use Only

When using this product do not use near heat or flame do not use in or around the eyes discontinue use if irritation and redness develop


 do not use on deep or punture wounds, consult your doctor

Directions

 apply gel liberally to unsoiled hands and rub in thoroughly  allow to dry without wiping or rinsing

Other Information

 store at room temperature

Inactive Ingredients:

Water, Aloe Barbadensies Leaf Juice, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D&C yellow #10, FD&C yellow #5, FD&C Blue #1

* Please review the disclaimer below.