Label: BOTANIKA AUSTRALIA ALOE VERA ANTI BACTERIAL 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 August 28, 2020

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  • Drug Facts

  • Active ingredient

    SD Alcohol 40-B 75% v/v

    Purpose

    Antiseptic

    USE

    • hand sanitizer to help reduce bacteria on the skin.
  • Warnings

    For external use only.

    Flammable. Keep away from fire and flame.

    When using this product

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

    Stop use and ask a doctor if

    • irritation and redness develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough on you palm to cover hands. Rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.

    Other information:

    • Store at 20℃ to 25℃ (68℉ to 77℉).
    • May discolor some fabrics or surface.
  • Inactive ingredients

    Purified Water (Aqua), Cross Polymer, Triethanolamine, Parfum (Fragrance), Citronellol, Linalool, Lilial, Benzyl Salicylate, Hexyl Cinnamic Aldehyde, Ceranil, Cumarin, Hydroxycitronellal, Amyl Cinnamic Aldehyde, Eugenol Cinnamyl Alcohol, Eugenol Cinnamyl Alcohol, Methyl Ionone, Benzyl Benzoate, Benzyl Alcohol, Citral, Iso Eugenol, Limonene

  • package

    label image

  • INGREDIENTS AND APPEARANCE
    BOTANIKA AUSTRALIA ALOE VERA ANTI BACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79978-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79978-009-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/28/2020
    Labeler - COGNESCENTI PTY. LTD. (745278551)
    Establishment
    NameAddressID/FEIBusiness Operations
    COGNESCENTI PTY. LTD.745278551manufacture(79978-009)
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