Label: SALUT STERILIZATION WATER- sterilization water liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 29, 2020

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  • 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 age
    • on open skin wounds
  • WHEN USING

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

  • STOP USE

    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

    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.

  • Package Label - Principal Display Panel

    1L

  • INGREDIENTS AND APPEARANCE
    SALUT STERILIZATION WATER 
    sterilization water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78127-101
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROCLOSENE SODIUM (UNII: 07M9U9U0LK) (CHLORINE - UNII:4R7X1O2820) TROCLOSENE SODIUM200 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78127-101-8312 in 1 CARTON05/28/2020
    1NDC:78127-101-081 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/28/2020
    Labeler - Huzhou Chunyi Biotech Co., Ltd (421148992)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huzhou Chunyi Biotech Co., Ltd421148992manufacture(78127-101) , label(78127-101)