NDC 80335-108 Planeaire Hands Hand Sanitizer

Ethyl Alcohol

  1. Labeler Index
  2. Everywhereaire Llc
  3. NDC: 80335-108 Planeaire Hands Hand Sanitizer

NDC Product Code 80335-108

NDC CODE: 80335-108

Proprietary Name: Planeaire Hands Hand Sanitizer What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Ethyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 80335 - Everywhereaire Llc

NDC 80335-108-02

Package Description: 60 mL in 1 BOTTLE, PUMP

NDC Product Information

Planeaire Hands Hand Sanitizer with NDC 80335-108 is a a human over the counter drug product labeled by Everywhereaire Llc. The generic name of Planeaire Hands Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Everywhereaire 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.

Planeaire Hands 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.
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TANGERINE (UNII: KH3E3096OO)
  • CORIANDER OIL (UNII: 7626GC95E5)
  • ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • WATER (UNII: 059QF0KO0R)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Everywhereaire Llc
Labeler Code: 80335
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: 12-21-2020 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.

Planeaire Hands Hand Sanitizer Product Label Images

Planeaire Hands 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

  • The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.Glycerol WaterOther inactive ingredients

Active Ingredient(S)

Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do Not Use

  • On open wounds or near eyes. In case of contact with eyes, rinse thoroughly with water.

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 if irritation or rash develops. If condition persists for more than 72 hours, consult a doctor.

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

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. If condtion persists for more than 72 hours, consult a doictor.

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

  • Wet hands thoroughly with product, rub hands, and allow to dry without wipingFor children under 6 years of age, use only under adult supervision to avoid swallowingnot recommended for infants

Wet hands thoroughly with product, rub hands, and allow to dry without wiping

For children under 6 years of age, use only under adult supervision to avoid swallowing

not recommended for infants

Other Information

  • Store between 15-30C (59-86F)do not store above 105FAvoid freezing may discolor some fabricsmay be harmful to some wood finishes and plastics

Inactive Ingredients

Aloe vera inner leaf, green tea extract, glycerin, carbomer, tangerine oil, coriander oil, sodium hydroxide, water

* Please review the disclaimer below.