Label: DR. DADDYS HAND SANITIZER- alcohol gel

  • NDC Code(s): 76884-0001-1
  • Packager: TB Healthcare Co., Ltd.
  • 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 May 12, 2020

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  • ACTIVE INGREDIENT

    Alcohol

  • INACTIVE INGREDIENT

    Water, Glycerin, Triethanolamine, Carbomer, Green Tea Extract, Aloe Extract, Sage Extract, Matricaria(Chamomilla) Extract

  • PURPOSE

    Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    ■ Store between 1-30C

    ■ Avoid freezing and excessive heat above 40C

  • WARNINGS

    For external use only. Flammable, Keep away from fire or flames.
    Do not use

    ■ in children less than 2 months of age

    ■ on open skin wounds
    when using this product keep out of eyes, ears, and mouth.
    Stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.
    Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    ■ Place 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.

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    DR. DADDYS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76884-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76884-0001-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - TB Healthcare Co., Ltd. (695035143)
    Registrant - TB Healthcare Co., Ltd. (695035143)
    Establishment
    NameAddressID/FEIBusiness Operations
    TB Healthcare Co., Ltd.695035143label(76884-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(76884-0001)
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