NDC 81456-201 Vita Plus Saniwipes

Alcohol, Chloroxylenol

NDC Product Code 81456-201

NDC 81456-201-01

Package Description: 65 g in 1 POUCH

NDC 81456-201-02

Package Description: 105 g in 1 POUCH

NDC Product Information

Vita Plus Saniwipes with NDC 81456-201 is a a human over the counter drug product labeled by Ainos Co., Ltd. The generic name of Vita Plus Saniwipes is alcohol, chloroxylenol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ainos Co., Ltd

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.

Vita Plus Saniwipes 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.

  • CHLOROXYLENOL .2 g/100g
  • ALCOHOL 3.97 g/100g

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.

  • WATER (UNII: 059QF0KO0R)
  • REGENERATED CELLULOSE (UNII: BX81F82EWG)
  • POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL) (UNII: 571593769G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • HEXYLDECANOL (UNII: 151Z7P1317)
  • POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Ainos Co., Ltd
Labeler Code: 81456
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: 01-25-2021 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: 12-31-2022 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.

Vita Plus Saniwipes Product Label Images

Vita Plus Saniwipes 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

Alcohol 3.97%Chloroxylenol 0.2%

Purpose

Antiseptic

Use[S]

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

Warnings

1) General- If medical measures are required, please show the product container or labeling.- When irritated due to exposure to the product, please visit a medical institution or doctor.- When directly exposed to the product, wash the exposed body parts or remove the exposed piece of the product.2) Oral exposure- If for some reason you eat or swallow the product, immediately take emergency measures and consult with a doctor.3) Dermal and eye exposure- In the case of coming into contact with your skin, wash with plenty of water and soap.- Immediately wash out if the product comes into contact with your eyes.- Wash out with clean water if the product comes into contact with your eyes or skin and consult with a doctor.4) Inhalation exposure- If you experience difficulty in breathing after inhaling the product, move to an area with fresh air and take a relax in a posture to perform comfortable breathing.

When Using This Product

In a sealed room, make sure to ventilate the space.

Stop Use And Ask A Doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

1. Remove one sheet and use it where sterilization and cleaning are required. 2. Adjust the number of uses according to the contamination range.

Other Information

Store away from direct sunlight and keep in a cool space.Do not reuse the wipes.

Inactive Ingredients

Water, Rayon, Polyester, Glycerin, Dipropylene Glycol, Hydroxyacetophenone, Hexyldecanol, Caprylyl Glycol, Polyglyceryl-10 Stearate, Tocopheryl Acetate, Dipotassium Glycyrrhizate

* Please review the disclaimer below.