NDC 77462-006 Storm Advanced Hand Sanitizer

Ethyl Alcohol

NDC Product Code 77462-006

NDC 77462-006-05

Package Description: 150 mL in 1 BOTTLE, SPRAY

NDC Product Information

Storm Advanced Hand Sanitizer with NDC 77462-006 is a a human over the counter drug product labeled by Sora Kozmetik Sanayi Ticaret Anonim Sirketi. The generic name of Storm Advanced Hand Sanitizer is ethyl alcohol. The product's dosage form is aerosol and is administered via topical form.

Labeler Name: Sora Kozmetik Sanayi Ticaret Anonim Sirketi

Dosage Form: Aerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).

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.

Storm Advanced 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 90.24 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.

  • PANTHENOL (UNII: WV9CM0O67Z)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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: Sora Kozmetik Sanayi Ticaret Anonim Sirketi
Labeler Code: 77462
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: 07-14-2020 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.

Storm Advanced Hand Sanitizer Product Label Images

Storm Advanced 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 Ingredient

Ethanol 90.24%

Purpose

Antiseptic

Uses

It is used for local disinfection of hands and skin. It is effective against microbes and bacteria. It provides easiness and hygiene in at home, at work, in crowded environments.

Warnings

For external use only.

DANGER: Flammable. Contents Under Pressure.

Do not use near heat, sparks, or flames. Vapors may ignite explosively & cause flash fire. Prevent build-up of vapors. Do not smoke. Turn off pilot light, stoves, heaters, and other sources of ignition during use and until all vapors are gone. Do not puncture or incinerate container. Do not expose to heat or store at temperatures about 120F. Use with adequate ventilation.

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develops.

Otc - When Using

When using this product Avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical attention.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets: Children under 6 years age should be supervised by an adult when using. If swallowed, get medical help or contact your Poison Control Center right away.

Directions

Spray hands thoroughly with product and rub into hands til dry.

Other Information

Store at room temperature or in a cool place.

Inactive Ingredients

Water, Panthenol (Vitamin B5), Glycerol, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis (Aloe Vera) Leaf Juice

* Please review the disclaimer below.