Label: MOISTURIZER HAND SANITIZER- benzalkonium chloride solution

  • 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 October 28, 2022

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.13%

  • PURPOSE

    ANTIMICROBIAL

  • USE

    FOR HAND SANITIZING TO DECREASE BACTERIA ON THE SKIN.

    RECOMMENDED FOR REPEATED USE.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

    IN CASE OF EYE CONTACT, FLUSH EYES WITH WATER. STOP USE AND ASK A DOCTOR IF IRRITATION, OR REDNESS DEVELOPS OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP.

  • DIRECTIONS

    SHAKE WELL BEFORE USE.

    SPRAY A SMALL AMOUNT OF PRODUCT INTO PALM OF HAND.

    RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS.

    RUB HANDS TOGETHER BRISKLY UNTIL DRY.

  • INACTIVE INGREDIENTS

    WATER, PROPYLENE GLYCOL, LINUM USITATISSIMUM (FLAX) SEED EXTRACT, OCIMUM TENUIFLORUM LEAF EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, GLUCONOLACTONE, CITRIC ACID, SODIUM BENZOATE, EUCALYPTUS GLOBULUS OIL

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Rinati_Moisturizing Hand Sanitizer 2oz

  • INGREDIENTS AND APPEARANCE
    MOISTURIZER HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76849-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FLAX SEED (UNII: 4110YT348C)  
    OCIMUM TENUIFLORUM TOP (UNII: 34T63W8ULS)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76849-101-1159 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/04/2020
    Labeler - Rinati Skin, LLC (109530208)
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