NDC 75432-002 Hand Sanitizer

Hypochlorous Acid

NDC Product Code 75432-002

NDC 75432-002-01

Package Description: 250 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer with NDC 75432-002 is a a human over the counter drug product labeled by Medek, Llc. The generic name of Hand Sanitizer is hypochlorous acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Medek, Llc

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.

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.

  • HYPOCHLOROUS ACID .0005 mg/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.

  • TROLAMINE (UNII: 9O3K93S3TK)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER 940 (UNII: 4Q93RCW27E)

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: Medek, Llc
Labeler Code: 75432
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-30-2020 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.

Hand Sanitizer Product Label Images

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

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:Hypochlorous Acid (0.0005% volume/volume (v/v)).Triethanolamine (1.2% v/v).Edetic Acid (0.05% v/v).Carbopol (1.0% v/v).Demineralized water.

Active Ingredient(S)

Hypochlorous Acid 0.0005% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic hand sanitizer to reduce germs on skin. For use when soap and water are not available.

Warnings

For external use only. Keep out of reach of children.

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor: if irritation, rash or redness occurs. These may be signs of a serious condition.

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor: if irritation, rash or redness occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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

Directions

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store below 83F (30C)Avoid freezing.

Inactive Ingredients

Demineralized water, triethanolamine, carbomer and stabilizers

* Please review the disclaimer below.