Label: HAND SANITIZING- isopropyl alcohol gel

  • NDC Code(s): 77110-600-01, 77110-600-02, 77110-600-03, 77110-600-04
  • Packager: Biominerales Pharma
  • 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 September 2, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredients

    Isopropyl alcohol – 70% v/v

  • Purpose

    Antiseptic

  • Inactive ingredients

    Deionized water, Carbomer, Propylene Glycol, Triethanolamine, Hydrogen Peroxide.

  • Use (s)

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

    For use when water and soap are not available.

  • Directions

    Rub thoroughly into hands for at least 30 seconds, allow to dry.

    Supervise children when they use this product.

    Adults and children 2 years and older:

    For occasional and personal domestic use.

  • Other information

    Store Between 15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above 40 °C (104 °F).

  • Cautions and warnings

    -
    For external use only
    -
    Flammable
    -
    Keep away from heat or flame
    -
    Keep out of reach of children

    -
    Do not use in children less than 2 months of age or on open skin wounds

    -
    When using this product keep our of eyes, ears and mouth.

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

    -
    These may be signs of a serious condition

    -
    Keep out of reach of children
    -
    If swallowed, get medical help or contact poison control center right away.

    Stop use and ask a doctor if irritation or rash occurs.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Hempire Farms, LLC
    150 E Palmetto Park Rd
    Boca Raton, FL 33432

  • PRINCIPAL DISPLAY PANEL - 473 mL Container Label

    USA
    HEMPIRE
    FARMS

    MADE IN
    USA

    KILLS HARMFUL BACTERIA/GERMS

    16 fl. Oz. (473 mL)

    HAND SANITIZING GEL with
    HEMP OIL & ALOE for moisturizing

    16 fl. oz.
    (473 mL)

    70 %
    v/v
    ADVANCED

    ISOPROPYL
    ALCOHOL
    PROTECTION

    PRINCIPAL DISPLAY PANEL - 473 mL Container Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Trolamine (UNII: 9O3K93S3TK)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77110-600-04236 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
    2NDC:77110-600-03473 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
    3NDC:77110-600-02946 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
    4NDC:77110-600-013785 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E09/01/2020
    Labeler - Biominerales Pharma (117489663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biominerales Pharma117489663MANUFACTURE(77110-600)