Label: D.THERAPINO ONE STEP HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 25, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    ethanol

  • INACTIVE INGREDIENT

    Alcohol
    Water
    Carbomer
    Aloe Barbadensis Leaf Extract
    Water
    Butylene Glycol
    1,2-Hexanediol
    Triethanolamine
    Menthol

  • PURPOSE

    hand sanitizer to help reduce bacteria that potentially can cause disease

    for use when soap and water are not available

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

    Supervise children in the use of this product.

    Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation or sensitization develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    D.THERAPINO ONE STEP HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58241-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58241-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
    2NDC:58241-0001-2300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
    3NDC:58241-0001-380 mL in 1 TUBE; Type 0: Not a Combination Product03/21/2020
    4NDC:58241-0001-450 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
    5NDC:58241-0001-5100 mL in 1 TUBE; Type 0: Not a Combination Product04/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/21/2020
    Labeler - David Cosmetic Co Ltd (695697845)
    Registrant - David Cosmetic Co Ltd (695697845)
    Establishment
    NameAddressID/FEIBusiness Operations
    David Cosmetic Co Ltd695697845manufacture(58241-0001) , label(58241-0001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!