Label: PURE SAFER GEL(ETHANOL)- hand sanitizer 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 May 25, 2020

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  • Active ingredient

    Ethyl Alcohol 70.0% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on skin.

  • Warnings

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

  • WHEN USING

    When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask doctor if iffitation or rash appears and lasts.

  • 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.

  • Inactive ingredients

    Water(Aqua), Carbomer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopherol, Triethanolamine, Propylene Glycol, FD&C Blue No.1, FD&C Yellow No.5

  • Directions:

    • Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other Information:

    • Store below 106°F. (41°C)
    • May discolor certain fabrics or surfaces.
  • Package Label - Principal Display Panel

    500mL NDC: 74142-201-50

  • INGREDIENTS AND APPEARANCE
    PURE SAFER GEL(ETHANOL) 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74142-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE (UNII: V5VD430YW9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74142-201-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/03/2020
    Labeler - Sinbad Co.,Ltd (693900611)
    Registrant - Sinbad Co.,Ltd (693900611)
    Establishment
    NameAddressID/FEIBusiness Operations
    CAREPHARM694639821manufacture(74142-201)
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