Label: HAND SANITIZER REFILL- alcohol liquid

  • 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 23, 2020

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  • Uses

    Uses

    * To decrease bacterias on the hand. Recommended for repeated use.

  • Active Ingredient

    Active Ingredient Purpose

    • Ethyl Alcohol 65%...................................Antiseptic
  • Warnings

    • For external use only- hands
    • When using this product keep out o f eyes. In case of contact, flush throughly with water.
    • Do Not Inhale or ingest.
    • Avoid contact with broken skin
    • Keep out of reach of children. In case of incidental ingestion seek professional assistance or contact a Poison Control Center inmediately.
    • Stop use and ask Doctor: if skin irritation develops.
    • Flammable: Keep away from heat and flame.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if

    * Irritation develops

  • Keep out of reach of children

    Keep out of reach of children. In case of incidental ingestion, see professional advice or contact a Poison Control Center inmediately.

  • Directions

    Directions: Wet hands throughly with product and allow to dry without wiping

    • For Children under 6 years of age do not use without supervision of an adult. Not recomended for infants
  • Inactive Ingredients

    Water, C10-30 Alkyl Acrylate Crosspolymer, Parfum(Fragrance), Limonene, Tromethamine, Linalool, potassium Sorbate, Geraniol, Sodium Benzoate

    Back Label

  • Questions?

    QUESTIONS OR COMMENTS: Visit Haanready.com

  • Uses

    Uses

    * To decrease bacterias on the hand. Recommended for repeated use.

  • Hand Sanitizer Refill

    Front Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER REFILL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79091-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
    WATER (UNII: 059QF0KO0R)  
    GERANIOL (UNII: L837108USY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79091-011-01100 mL in 1 POUCH; Type 0: Not a Combination Product09/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2020
    Labeler - HAAN BRAND SL (468886727)
    Registrant - HAAN BRAND SL (468886727)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Magrina SL460356033manufacture(79091-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    HAAN BRAND SL468886727label(79091-011)
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