NDC 53325-125 Boson

Alcohol

NDC Product Code 53325-125

NDC 53325-125-01

Package Description: 296 mL in 1 BOTTLE, PLASTIC

NDC 53325-125-02

Package Description: 354.8 mL in 1 BOTTLE, PLASTIC

NDC 53325-125-03

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Boson with NDC 53325-125 is a a human over the counter drug product labeled by Aliml Nutritional Products, Inc.. The generic name of Boson is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Aliml Nutritional Products, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Boson 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

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)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • 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: Aliml Nutritional Products, Inc.
Labeler Code: 53325
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: 07-08-2020 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.

Boson 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 Alcohol 75% v/v.

Purpose

Antiseptic

Use

  • Hand disinfection - follow the standard method to use soap to wash hands, rinse with running water, dry with sterile towel, then direct spray this product on hands and forearms until moist, wait for 3 minutes, rub hands until dry.General object surface disinfection - directly spray on the object surface for until moist, waif for 3-5 minutes.

Warnings

  • For external use only - handsFlammable, keep away from heat and flameDo not useIn children less than 2 months of ageOn open skin woundWhen using the product keep out of eyes, in case of contact with eyes, flush thoroughly with water

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.For children under 6, use only under adult supervision.Not recommended for infants.

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)Extremely flammableSeal for preservation, keep away from sunlight and don't expose to temperature exceeds 50C. Don't piece or burnDon't spray on open flame or any flammable material. Keep it away from the reach of children. Don't spray toward eyesExternal disinfectant should not be taken orally and kept out the reach of childrenUse with caution if allergic to alcoholIt should not be used to disinfect fat-soluble surfacesThe is product is irritating to wounds or mucous membranes

Inactive Ingredients

Purified water, glycerin, Hydrogen peroxide

* Please review the disclaimer below.