Label: DC HUDABEAUTY 75% ALCOHOL HAND RINSE FREE DISINFECTANT- 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 April 26, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin without soap and water

  • Warnings

    For external use only.

    Flammable. Keep away from heat and flame

    Do not use in eyes, if this happens, rinse thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation develops and persists for more than 72 hours. If ingested, get medical help or contact a poison control center right away

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping
  • Inactive ingredients

    Water, Carbomer, Triethanolamine

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    DC HUDABEAUTY 75% ALCOHOL HAND RINSE FREE DISINFECTANT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75511-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75511-002-0180 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    2NDC:75511-002-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    3NDC:75511-002-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/26/2020
    Labeler - ZHEJIANG HUDA COSMETICS CO., LTD. (554530177)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG HUDA COSMETICS CO., LTD.554530177manufacture(75511-002)