Label: OLLIE HAND SANITIZER- alcohol liquid

  • NDC Code(s): 81634-001-01
  • Packager: F.P. Aromatics Singapore Pte Ltd
  • 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 April 11, 2023

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  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    To sanitize hand when soap and water are not available.

  • Warnings

    For external use only. Keep away from fire or flame.

    Do not use

    • on open wounds
    • on children less than 4 months of age.

    When using this product, keep out of eyes, ears, mouth.
    Stop use and ask a doctor if irritation or rash occurs.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Direction

    • Spray on hands and rub them together gently
    • Supervise children under 6 years of age in the use of this product
  • KEEP OUT OF REACH OF CHILDREN

  • Other information

    Store between 15° - 30°C (59° - 86°F)

  • Inactive ingredient

    Aloe vera, Orange oil, Peppermint oil, Tea tree oil, Water

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    OLLIE HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81634-001
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81634-001-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2021
    Labeler - F.P. Aromatics Singapore Pte Ltd (595391354)
    Establishment
    NameAddressID/FEIBusiness Operations
    F.P. Aromatics Singapore Pte Ltd595391354manufacture(81634-001)
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