Label: 24K SALLY HERSHBERGER INSTANT 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 April 29, 2020

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  • Drug Facts

  • Active ingredients

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin
  • Warnings

    Flammable; Keep away from fire or flame.

    For external use only

    Do not use

    • on children less than 2 months of age
    • on open skin wounds

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears and lasts

    Keep out of reach of children.

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

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Aqua (Water), Isopropyl Alcohol, Carbomer, Glycerin, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

  • Company Information

    Manufactured in Italy

    Originitalia srl

    36030 Caldogno (VI)

    www.sallyhershberger.com

  • Product Packaging - 100 ml bottle

    24K

    SALLY HERSHBERGER

    INSTANT

    HAND SANITIZER

    TEA TREE OIL, ALOE VERA

    CONTAINS 70% ALCOHOL

    3.4 fl.oz./100 ml

    hand sanitizer

  • INGREDIENTS AND APPEARANCE
    24K SALLY HERSHBERGER INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76607-001
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76607-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Sally Hershberger Professional Haircare, LLC (798803404)
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