Label: ANTIBACTERIAL HAND SANITIZING- 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 May 19, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Use

    • Antibacterial hand sanitizing gel to help killing bacteria and germs as antiseptic on the skin. For use when soap and water are not available.
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product

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

    Stop use and ask doctor

    If irritation, rash or allergy 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

  • Directions

    • Apply. Put enough product on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds.  recommended for repeated use.
    •  Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 59-86ºF (15-30ºC) avoid freezing and excessive heat above 104ºF (40ºC)

  • Inactive ingredients

    • Deionized Water. Carbomer. Panthenol. D-Limonene. DMDM Hydantoin. Disodium EDTA Triethanolamine.

  • Package Labeling

    Label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZING 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78080-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78080-001-00250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/07/2020
    Labeler - MaKMaC Inc (128886705)
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