NDC 75023-002 Hand Sanitizer

Isopropyl Alcohol

NDC Product Code 75023-002

NDC 75023-002-01

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC 75023-002-02

Package Description: 100 mL in 1 BOTTLE, DISPENSING

NDC 75023-002-03

Package Description: 100 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Hand Sanitizer with NDC 75023-002 is a a human over the counter drug product labeled by Sun Wave Wellness, Llc. The generic name of Hand Sanitizer is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Sun Wave Wellness, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

  • ISOPROPYL 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.

  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Sun Wave Wellness, Llc
Labeler Code: 75023
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: 07-05-2020 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

Use(S)

To help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

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

Do Not Use

  • On children less than 2 months of ageon open skin woundsaround eyesin ears and mouth

When Using This Product

  • Keep out of eyes, ears, and mouth.Incase of contact with eyes, rinse eyes thoroughly with water.avoid contact with broken skindo not inhale or ingest

Stop Use And Ask A Doctor If

Irritation or rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and exessive heat above 40C (104F)

Inactive Ingredients

Aloe Barbadenisis (leaf) Extract, Fragrance, Glycerin, Purified Water

Manufactured By:

Sun Wave Wellness, LLC1419 Chaffee Drive #101Titusville, FL 32780-7933sunwavesanitizer.com

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

* Please review the disclaimer below.