Label: SANITIZERX- hand sanitizer gel 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 September 1, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol75%

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria that potentially can cause disease

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyesrinse eye thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

  • Do not use

    /

  • WHEN USING SECTION

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyesrinse eye thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

  • STOP USE

    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

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

  • Directions

    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

  • Other information

    Store between 15C-30C(59F-86F)
    Avoid freezing and excessive heat above 40C(104F)

  • Inactive ingredients

    purified water
    glycerin
    Hydrogen peroxide

  • Package Label - Principal Display Panel

    78414-003-02 59ml

  • INGREDIENTS AND APPEARANCE
    SANITIZERX 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78414-004
    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
    1,1-BIS(TERT-BUTYLPEROXY)CYCLOHEXANE (UNII: JK62J3E3Q4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78414-004-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - Guangzhou caolvxiang Biotechnology Co.,Ltd (547949400)
    Registrant - Guangzhou caolvxiang Biotechnology Co.,Ltd (547949400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou caolvxiang Biotechnology Co.,Ltd547949400manufacture(78414-004)
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