NDC 75306-003 Skintillate Hand Sanitizer

Alcohol, Isopropyl Alcohol

NDC Product Code 75306-003

NDC 75306-003-01

Package Description: 30 mL in 1 BOTTLE, PLASTIC

NDC 75306-003-02

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC 75306-003-03

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 75306-003-04

Package Description: 100 mL in 1 BOTTLE, PLASTIC

NDC 75306-003-05

Package Description: 120 mL in 1 BOTTLE, PLASTIC

NDC 75306-003-06

Package Description: 160 mL in 1 BOTTLE, PLASTIC

NDC 75306-003-07

Package Description: 200 mL in 1 BOTTLE, PLASTIC

NDC 75306-003-08

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Skintillate Hand Sanitizer with NDC 75306-003 is a a human over the counter drug product labeled by D-time Limited Liability Company. The generic name of Skintillate Hand Sanitizer is alcohol, isopropyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: D-time Limited Liability Company

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.

Skintillate 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
  • ISOPROPYL ALCOHOL 5 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)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • SODIUM PYRUVATE (UNII: POD38AIF08)

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: D-time Limited Liability Company
Labeler Code: 75306
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: 05-01-2020 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.

Skintillate Hand Sanitizer Product Label Images

Skintillate 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

Active Ingredients

Alcohol (80%)Ethyl Alcohol (75%), Isopropyl Alcohol (5%)

​Purpose

Antiseptic skin cleanser

Use

For personal hand hygiene to help prevent the spread of bacteria.

Warnings

For external use only.When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult a healthcare professional if irritation develops.Flammable. Keep away from heat and flame.

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

Adults and children over 2 years: For occasional and personal domestic use. Supervise children when they use this product. Spray onto hands and rub thoroughly for at least 30 seconds. Allow to dry.

Inactive Ingredients

Water, Hydrogen Peroxide , Glycerin, Hyaluronic Acid, Bergamot leaf oil, Lavender Flower Oil, Centella Asiatica Extract, Sodium pyruvateOther informationStore at 680 to 700 F (200 to 250C). May discolor certain fabrics or surfaces.Questions? 1-844-800-6858

* Please review the disclaimer below.