Label: KORA DAILY SAFE 62- hand sanitizer 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 December 15, 2020

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  • Active Ingredient(s)

    Alcohol 62% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic. Hand Sanitizer

  • Use

    For hand sanitizer to reduct microorganisms that potentially can cause diseases. Recommended for repeated use.

  • Warnings

    For external use on hands only. Flammable. Keep away from fire or flame.

  • Do not use

    in or near the eyes.In case of contact with eyes, rinse eyes thoroughly with water.

  • WHEN USING

    When using this product do not use or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation, swelling or redness develops.

  • STOP USE

    Stop use and ask a doctor if irritation, swelling or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Put enough product in your palm to cover hands and rub hands together briskly until dry.

    Children under 6 years of age should be supervised when using.

  • Other information

    Store below 110°F (43°C)

  • Inactive ingredients

    Ethyl alcohol, Sterile Distilled water, Carbomer, Triethanolamine, Polyglyceryl-2-triisostearate, Dipropylene glycol, L-Menthol, Sodium Hyaluronate 1%, Lemon fragrance

  • PRINCIPAL DISPLAY PANEL

    500mL

    NDC:75504-162-11

    Daily Safe 62 Gel

  • INGREDIENTS AND APPEARANCE
    KORA DAILY SAFE 62 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75504-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.3 mL  in 100 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.1 mL  in 100 mL
    DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.2 mL  in 100 mL
    LEVOMENTHOL (UNII: BZ1R15MTK7) 0.1 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
    POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A) 2 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 34.8 mL  in 100 mL
    LEMON OIL (UNII: I9GRO824LL) 0.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75504-162-11500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    Labeler - Kora Holdings LLC (695692001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sellus690026575manufacture(75504-162)
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