Label: HAND SANITIZER- alcohol spray

  • 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 January 9, 2021

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Topical Antimicrobial

  • Purpose

    Topical Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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

    • Spray a small amount of product into palm of hand.
    • Rub thoroughly over all surfaces of both hands.
    • Supervise children under 6 years of age when using this product.
  • Other information

    • Store between 10-30C (59-86F)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    water, glycerin, citrus limon (lemon) peel oil, limonene, citral

  • Package Label - Principal Display Panel

    120 mL NDC: 74753-784-12

    250 mL NDC: 74753-784-25

    250ml

    120ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74753-784
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL (UNII: I9GRO824LL) 0.0323 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 18.45 mL  in 100 mL
    CITRAL (UNII: T7EU0O9VPP) 0.0017 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74753-784-12120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
    2NDC:74753-784-25250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2020
    Labeler - FIFTEEN DEGREES co.,ltd (694982014)
    Registrant - FARMER'S GRAIN KOREA LTD (694439983)
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