NDC 93068-003 Sanitizer

Sanitizer

NDC Product Code 93068-003

NDC 93068-003-01

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

Sanitizer with NDC 93068-003 is a a human over the counter drug product labeled by Kangsheng Medical Technology (wenzhou) Co. , Ltd. The generic name of Sanitizer is sanitizer. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Kangsheng Medical Technology (wenzhou) 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.

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.

  • BENZALKONIUM .1 g/100mL
  • METHENAMINE .27 g/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.

  • 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: Kangsheng Medical Technology (wenzhou) Co. , Ltd
Labeler Code: 93068
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-22-2020 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.

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(S)

Hexamine:0.23%-0.27%Benzalkonium bromide:0.12%-0.14%

Purpose

Antiseptic

Use

To decrease bacteria on the skin that could cause diseaserecommended for repeat useUse without water

Warnings

For external use only. Keep out of reach of children, in case of accidental ingestion,seek professional assistance.Discontinue if skin becomes irritated and ask a doctorDo not use it together with peroxide and detergentKeep in a cool and dry place

Do Not Use

It together with peroxide and detergent

Otc - When Using

.

Otc - Stop Use

Discontinue if skin becomes irritated and ask a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.in case if accidental ingestion,seek professional assistance

Directions

Wet hands throughly with product and rub until dry without wipingFor children under 6 years old,use only under adult supervision

Inactive Ingredients

Water

* Please review the disclaimer below.