Label: ALV71 PURE SANITIZER 100ML- 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 April 29, 2020

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  • Active Ingredient(s)

    Alcohol 70%

  • Purpose

    Purpose: Antiseptic

  • Use

     Hand sanitizing to help reduce bacteria on the skin

  • Warnings

     For external use only.
     Flammable, keep away from fire or flame.
     When using this product, avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.
     Stop use and ask a doctor if irritation or redness 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 immediately.

  • Directions

     Take suitable amount of sanitizer in the hand. Wet thoroughly and rub hands together until dry

  • Other information

     Store in room temperature 0~30℃

  • Inactive ingredients

     Water(Aqua), Carbomer, Triethanolamine, Polysorbate 20, Camellia Sinensis Leaf Extract, Glycerin, Tocopheryl Acetate, Fragrance(Parfum)

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    ALV71 PURE SANITIZER 100ML 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76886-002
    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
    Water (UNII: 059QF0KO0R)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76886-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2020
    Labeler - MIKOLAB CO .LTD (695791492)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIKOLAB CO .LTD695791492label(76886-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    HEALKINBIO CO.694039685manufacture(76886-002)
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