Label: FIRST SAFETY INSTANT 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 April 16, 2020

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  • ACTIVE INGREDIENT

    Active ingredient                                  Purpose

    Ethyl Alcohol                70%      ...        Antiseptic

  • PURPOSE

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get meical help or contact Poison Control Center right away.

  • INDICATIONS & USAGE

    keep out of eyes,ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

  • WARNINGS

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

    Do not use:

    • On open skin wounds
    • in children less than 2 months of age
  • 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.

    Other information:

    • Store between 59°-86℉ （15°-30℃）
    • Avoid freezing and excessive heat above 104℉ （40℃）
  • INACTIVE INGREDIENT

    Glycerin, Aloe， water, Barbadensis gel, Carbomer

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    FIRST SAFETY INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52174-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52174-008-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
    2NDC:52174-008-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
    3NDC:52174-008-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2020
    Labeler - Ningbo BST Clean And Care Products Co., Ltd (529352816)
    Registrant - Ningbo BST Clean And Care Products Co., Ltd (529352816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo BST Clean And Care Products Co., Ltd529352816manufacture(52174-008)
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