NDC 77760-101 Salut Sterilization Water

Sterilization Water

NDC Product Code 77760-101

NDC 77760-101-83

Package Description: 12 BOTTLE, PLASTIC in 1 CARTON > 1 L in 1 BOTTLE, PLASTIC (77760-101-08)

NDC Product Information

Salut Sterilization Water with NDC 77760-101 is a a human over the counter drug product labeled by Wuxi Reba Bestplus Technology Co., Ltd. The generic name of Salut Sterilization Water is sterilization water. The product's dosage form is liquid and is administered via extracorporeal form.

Labeler Name: Wuxi Reba Bestplus Technology 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.

Salut Sterilization Water 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.

  • TROCLOSENE SODIUM 200 mg/L

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 CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Extracorporeal - Administration outside of the body.
  • Extracorporeal - Administration outside of the body.

Product Labeler Information

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

Labeler Name: Wuxi Reba Bestplus Technology Co., Ltd
Labeler Code: 77760
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: 06-01-2020 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.

Salut Sterilization Water Product Label Images

Salut Sterilization Water 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)

Sodium dichloroisocyanurate 0.02% w/w. Purpose: Antimicrobial

Purpose

Antimicrobial.

Use

This product is indicated use for disinfection of air, object surface, and skin; prevent of cross infection.Effectively disinfect against Staphylococcus aureus, Escherichia coli, Candida albicans.

Warnings

External use only. Do not mix with any other liquids.

Do Not Use

  • On children less than 2 months of ageon open skin wounds

Otc - When Using

When using: avoid direct contact with eyes and damaged skin; if it gets in your eyes accidentally, please rinse with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

This product should be placed out of reach of children.

Directions

1. General object surface disinfection, with this product directly and evenly sprayed, wipe or soak, stay for 30 minutes.2. Air disinfection, directly and evenly sprayed in the air, 5 ml per cubic meter of space action 2-5 minutes.3. When disinfecting fruits and vegetables, rinse with tab water and spray, wipe or soak directly with this product for 20 minutes.4. When disinfecting skin, with this product directly and evenly sprayed, wipe and stay for 5 minutes.

Other Information

1. Storage in cool place and avoid directly sunlight, do not mix any other liquids.2. May slightly reaction with carbon steel products, avoid long period immersing, wipe off quickly after spraying.

Inactive Ingredients

Trisodium citrate dihydrate, Citric acid monohydrate, Sodium chloride, Water.

* Please review the disclaimer below.