Label: HAND SANITIZER- alcohol gel

  • 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 15, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    for handwashing to decrease bacteria on the skin.

    Recommended for repeated use

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in the eyes. In case of contact rinse eyes thoroughly with water.
  • WHEN USING

    In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.


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

  • 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

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

  • Directions

    • Apply products to hands
    • Briskly rub hands together until dry
    • Supervise children under 6 years in the use of this product
  • Other information

    • Store below 100F (43C)
    • May discolor certain fabrics
  • Inactive ingredients

    distilled water, glycerin, rosemary, basil oil, aloe vera, vitamin e, azadirachtae indicae oil, essential oil, carbomer 940, tween 20

  • Package Label - Principal Display Panel

    250 mL NDC: 90076-100-01

    90076-100-01

    1000 mL NDC: 90076-100-02

    90076-100-02

    5L NDC: 90076-100-03

    90076-100-03

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90076-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    ROSEMARY (UNII: IJ67X351P9) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 22.5 mL  in 100 mL
    BASIL OIL (UNII: Z129UMU8LE) 1.45 mL  in 100 mL
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.6 mL  in 100 mL
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) 0.5 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90076-100-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:90076-100-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:90076-100-035000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - LibertyWare LLC (949700595)
    Registrant - LibertyWare LLC (949700595)
    Establishment
    NameAddressID/FEIBusiness Operations
    LibertyWare LLC949700595manufacture(90076-100)
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