Label: NNP HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 3, 2020

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  • Drug Facts

  • Active Ingredient

    Alcohol 69.99% v/v

    Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease.
    • Recommended for repeated use.
  • Warnings

    • For External Use Only
    • Flammable
    • Keep Away From Fire or Flame

    When Using this Product

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

    Stop Use and Ask a Doctor if

    • Irritation or redness develops
    • Condition persists for more than 72 hourse.

    Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Pleace enough product on hands to cover all surfaces.
    • Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other Information

    • Do not store above 105°F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics.
  • Inactive Ingredients

    Water, Propylene, Glycol, Glycerin, Carbomer, Triethanolamine, Tocopheryl Acetate, Aloe Barbadensis Extract.

  • Package Labeling: 60ml

    Label

  • Package Labeling: 300ml

    Label2

  • Package Labeling: 1000ml

    bottle

  • INGREDIENTS AND APPEARANCE
    NNP HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78462-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6999 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE (UNII: AUG1H506LY)  
    ETHYLENE GLYCOL (UNII: FC72KVT52F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78462-007-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    2NDC:78462-007-10300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    3NDC:78462-007-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/25/2020
    Labeler - Nevada Zona Libre, S.A. (853778397)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Huanyan Daily Chemical Products Co., Ltd554527491manufacture(78462-007)
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