Label: NINEBIO SANITIZER GEL- 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 July 28, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    Water, Glycerin, butylene glycol, carbomer, triethanolamine, rosmarinus officinalis (rosemary) leaf extract, paeonia suffruticosa bark extract, aloe barbadensis leaf extract, calendula officianalis flower extract

  • PURPOSE

    Antiseptic

    instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

    instant hand antiseptic to decrease bacteria on the skin
    recommended for repeated use

    hand sanitizer to help reduce bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

    Supervise children in the use of this product.

    Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation or sensitization develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NINEBIO SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73932-0014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73932-0014-150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    2NDC:73932-0014-2100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    3NDC:73932-0014-3500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    4NDC:73932-0014-43780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/29/2020
    Labeler - AT Bio Pharm Co Ltd (695742996)
    Registrant - AT Bio Pharm Co Ltd (695742996)
    Establishment
    NameAddressID/FEIBusiness Operations
    AT Bio Pharm Co Ltd695742996manufacture(73932-0014)
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