Label: INSTANT HAND SANITIZER LAVENDER- alcohol 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 April 24, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts

  • 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

    Place enough product in your palm to thoroughly spread on both hands and rub into the skin untill dry

    Children under 6 years of age shoud be supervised when using this 

  • Other information

    Do not store above 106F (41C)

    May discolor certain fabrics or surfaces

  • Inactive ingredients

    Water, lavandula angustufolia (lavender) flower extract, carbomer, fragrance, propylene glycol, glycerin, tocopheryl acetate, triethanolamine, DC Red No 33, FD C Blue No 1

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER LAVENDER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76114-006
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76114-006-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - Zhejiang Aidi Cosmetics Co., Ltd (530876820)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd (530876820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Aidi Cosmetics Co., Ltd530876820manufacture(76114-006)
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