NDC 70956-011 Fresh Citrus Hand Sanitizer

Alcohol

NDC Product Code 70956-011

NDC 70956-011-01

Package Description: 250 mL in 1 BOTTLE

NDC Product Information

Fresh Citrus Hand Sanitizer with NDC 70956-011 is a a human over the counter drug product labeled by Absara Cosmetics S.a.p.i De C.v.. The generic name of Fresh Citrus Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Absara Cosmetics S.a.p.i De C.v.

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.

Fresh Citrus 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 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Absara Cosmetics S.a.p.i De C.v.
Labeler Code: 70956
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: 05-25-2020 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.

Fresh Citrus Hand Sanitizer Product Label Images

Fresh Citrus 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

Drug Facts

Distributed by: Cross Border Manufacturers Inc, 8 The Green Ste #10166 Dover, DE 19901

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame. For external use only.Do not ingest, if swallowed seek medical help.Avoid contact with eyes.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Children under 10 years old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

Directions

Apply the gel on the hands and rub gently for 25 seconds until the product evaporates.

Other Information

Store below 106° F (41°C), May discolor certain fabrics or surfaces.

Inactive Ingredients

Demineralized water, glycerin, carbomer, Fragrance, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

* Please review the disclaimer below.