NDC 64942-1740 Skinsei

Ethyl Alcohol Liquid

NDC Product Code 64942-1740

NDC 64942-1740-1

Package Description: 118 mL in 1 CONTAINER

NDC Product Information

Skinsei with NDC 64942-1740 is a a human over the counter drug product labeled by Conopco Inc. D/b/a/ Unilever. The generic name of Skinsei is ethyl alcohol liquid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Conopco Inc. D/b/a/ Unilever

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.

Skinsei 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 700 mg/mL

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.

  • CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Conopco Inc. D/b/a/ Unilever
Labeler Code: 64942
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: 06-01-2020 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.

Skinsei Product Label Images

Skinsei 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

Skinsei Hand Sanitizer - Alcohol Liquid

Skinsei Hand Sanitizer

Drug Facts

Active ingredientEthyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use

Warnings

Flammable. Keep away from fire or flame

For external use only

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.
When using this product avoid contact with eyes · In case of contact, flush eyes with water, call a doctor · Avoid contact with broken skin
Do not drink. Not edible.

In case of accidental ingeston seek professional assistance or contact a Poison Contro Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
Children should only use this product under adult supervision

Directions

• Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. Recommended for repeated use.

Other Information

• Do not store above 104˚F (40˚C). May discolor some fabrics · harmful to wood finishes and plastics

Inactive Ingredients

Aqua (Water), Carthamus Tinctorius (Safflower) Oleosomes, Polyacrylate Cross Polymer - 6 Hydroxyethyl Cellulose, Glycerin.

Otc - Questions

(800) 621-2079.

* Please review the disclaimer below.