Label: NUVALU HAND SANITIZER GUAVA BURST 1OZ- ethyl 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 March 11, 2021

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  • Drug Facts Active Ingredient

    Ethyl Alcohol 70 percent

  • Purpose

    Antimicrobial

  • Features

    • To decrease bacteria on the skin that could cause disease.
    • Recommended for repeated use.
    • Use anywhere without water.
  • Directions

    • Wet hands thoroughly with product and rub until dry without wiping.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • When using this product

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • Do not inhale or ingest.
    • Avoid contact with broken skin.
  • Other information

    • Do not store above 105 Fahrenheit
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • Warnings

    • For external use only.
    • Flammable. Keep away from heat and flame.
    • Discontinue if skin becomes irritated and ask a doctor.
  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Inactive Ingredients

    Water, Carbomer, Fragrance, Glycerin, Propylene Glycol, Triethanolamine, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, FD&C Red No.40, FD&C Yellow No.5

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NUVALU HAND SANITIZER GUAVA BURST 1OZ 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72520-118
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72520-118-4829 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2021
    Labeler - JC SALES (610969578)
    Registrant - JC SALES (610969578)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(72520-118)
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