Label: HAND SANITIZER- antiseptic liquid

  • 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 August 31, 2020

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  • Uses

    Uses

    * Healthcare personnel Handwash. Significant reduce the amount of bacterias on the hands and forearms.

  • Active Ingredient

    Active Ingredient Purpose

    • Isopropyl Alcohol 60%...................................Antiseptic
    • Chlorhexidine gluconate 0.5%..........................Antiseptic
  • Warnings

    • For external use only
    • When using this product avoid contact with eyes. In case of contact, flush with water for several minutes.
    • Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
    • Stop use and ask Doctor: if skin irritation develops when using this product
    • Flammable: Keep away from heat and flame. Highly flammable liquid and vapor/

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    * Irritation develops while using this product

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    Directions: Place enough product in your palm to throughly cover your hands.

    • Rubs hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product
  • Inactive Ingredients

    sodium lauryl ether sulfate, cocamide DEA, EDTA disodium salt, ethylene glycol polymer, propylene glycol dicaprate, water

  • Questions?

    QUESTIONS OR COMMENTS: Phone: (786) 599-2764. 24 hours a day, 7 days a week

  • Uses

    Uses

    * Healthcare personnel Handwash. Significant reduce the amount of bacterias on the hands and forearms.

  • Hand Soap

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    antiseptic liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78797-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL60 mg  in 1 mL
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78797-011-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2020
    Labeler - GRUPO PIRRETEAM SA DE CV (951579014)
    Registrant - GRUPO PIRRETEAM SA DE CV (951579014)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRUPO PIRRETEAM SA DE CV817531659label(78797-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    KUII PRODUCTOS DE LIMPIEZA SA DE CV951578840manufacture(78797-011)
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