Label: ADVANCED PROTECTION HAND SANITIZING- isopropyl 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 31, 2020

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  • 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.

  • 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

  • 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).

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Biominerales Pharma, LLC
    150 E Palmetto Park Rd
    Boca Raton, FL 33432

  • PRINCIPAL DISPLAY PANEL - 3,785 ml Container Label

    ADVANCED PROTECTION
    HAND SANITIZING GEL

    BIOMINERALES PHARMA

    KILLS HARMFUL BACTERIA/GERMS

    1 Gallon
    (3,785ml)

    70%
    v/v
    ISOPROPYL
    ALCOHOL

    PRINCIPAL DISPLAY PANEL - 3,785 ml Container Label
  • INGREDIENTS AND APPEARANCE
    ADVANCED PROTECTION HAND SANITIZING 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77110-700
    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:77110-700-04236 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
    2NDC:77110-700-03473 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
    3NDC:77110-700-02946 mL in 1 CONTAINER; Type 0: Not a Combination Product09/01/2020
    4NDC:77110-700-013785 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(77110-700)
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