Label: SOLGREAT- 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 June 8, 2020

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  • Active Ingredient

    Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use(s)

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame.

    Do not use

    • in 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 occurs. These may be signs of a serious condition.

  • 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 on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-300C (59-860F)
    • Avoid freezing and excessive heat above 400C (1040F)
  • Inactive ingredients

    aminomethyl propanol, carbomer, glycerin, hydrogen peroxide, purified water USP, tocopheryl acetate.

  • Package Label - Principal Display Panel

    60 mL

    60 mL

    237 mL

    237 mL

    500 mL

    500 mL

    1000 mL

    1000 mL

    3785 mL

    3785 mL

    1000000 mL

    1000000 mL

  • INGREDIENTS AND APPEARANCE
    SOLGREAT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73913-008
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73913-008-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    2NDC:73913-008-02237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    3NDC:73913-008-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    4NDC:73913-008-041000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    5NDC:73913-008-053785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    6NDC:73913-008-061000000 mL in 1 TANK; Type 0: Not a Combination Product06/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2020
    Labeler - PANATURAL USA, INC. (029572239)
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