Label: SANUS STERILE SAFETY SET- sterile safety set kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 28, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    70% Isopropyl Alcohol in swab(wipe).

  • Directions (Swab)

    Wet hands thoroughly with product and allow to dry. When finished, discard wipe in trash receptacle. Do not flush. Supervise children under 6 years of age when using this product to avoid swallowing.

  • Warnings

    Flammable. Keep away from heat or flame.

  • Inactive Ingredients

    Purified water USP.

  • INDICATIONS & USAGE

  • Keep out of reach of children

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

  • Purpose (Swab)

    Antiseptic Cleanser

  • Sterile Set

    Surgical Mask 1 PCS

    Alcohol Swab 6*8: 2 PCS

    Nitrile Glove M: 2 PCS

  • PRINCIPAL DISPLAY PANEL

    set

    sterile set

  • INGREDIENTS AND APPEARANCE
    SANUS STERILE SAFETY SET 
    sterile safety set kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79764-000
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79764-000-011 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package07/28/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 32 PATCH 2 mL
    Part 1 of 3
    RORO HEALTHCARE DISPOSABLE FACE MASK RORO MEDICAL DISPOSABLE FACE MASK 
    face mask (except n95 respirator) for general public/healthcare personnel per iie guidance cloth
    Product Information
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62) 66 
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalC4862307/28/2020
    Part 2 of 3
    DISPOSABLE NITRILE EXAMINATION GLOVE 
    polymer patient examination glove cloth
    Product Information
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLONITRILE (UNII: MP1U0D42PE) 100 
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalLZA07/28/2020
    Part 3 of 3
    JUNIPER CLEAN ALCOHOL SWAB 
    70% alcohol swab swab
    Product Information
    Item Code (Source)NDC:76557-002
    Route of AdministrationTOPICAL, CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76557-002-011 mL in 1 PATCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/28/2020
    Labeler - SANUS SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETI (533144738)