Label: DISINFECTION WASH FREE HAND SANITIZER- sodium hypochlorite 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 April 2, 2020

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  • ACTIVE INGREDIENT

    Active ingredient

    Sodium hypochlorite

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    Hand sanitizer to help reduce bacteria on the skin recommended for repeated use.

  • WARNINGS

    Warnings

    • Flammable
    • Keep away from fire or flame
    • For external use only

    When using this product

    • avoid contact with eyes in case of eye contact immediately flush eyes with water, call a doctor
    • avoid contact with broken skin
    • Discontinue use if irritation or redness develops. If condition persists from more than 72 hours, consult a doctor
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children should only use this product unde adult supervision. Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • OTHER SAFETY INFORMATION

    Other information

    • Do not store above 150F.
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • DOSAGE & ADMINISTRATION

    Directions

    • Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. Recommended for repeated use.
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis leaf extract, caprylyl glycol, carbomer, glycerin siopropyl alcohol, isopropyl alcohol myristate, Hyrochloric acid, sodium chloride

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTION WASH FREE HAND SANITIZER 
    sodium hypochlorite liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE120 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-010-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/02/2020
    Labeler - Davemed Healthcare Co., Ltd. (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd529128716manufacture(70897-010)