Label: SOLIMO- 70% clear ethanol gel 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 September 2, 2020

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

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Warnings

    FLAMMABLE

    For external use only

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

    Apply gel liberally to unsoiled hands and rub in thoroughly.

    Allow to dry without wiping or rinsing.

  • Other information

    Store at room temperature

  • Inactive ingredients

    Water, Carbomer, Glycerin, Diidopropylamine, Isopropyl Myristate.

  • Keep out of reach of children

    Keep out of reach of children

  • When using this product

    When using this product

    • do not use near heat or flame
    • do not use in or near eyes
    • discontinue use if irritation and redness develop
    • do not use on deep or puncture wounds consulft your doctor
  • Uses

    • to sanitizer hands without requiring water or a rinse
    • help reduce bacteria that can cause disease
  • Product label

    Label

  • INGREDIENTS AND APPEARANCE
    SOLIMO 
    70% clear ethanol gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-527
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.37 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.174 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 33.78 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.355 mL  in 100 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.108 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.217 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-527-86236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - Amazon.com Services LLC (128990418)
    Registrant - Carrollclean (081222623)
    Establishment
    NameAddressID/FEIBusiness Operations
    CarrollCLEAN081222623manufacture(72288-527)