Label: ANTISEPTIC GEL- 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 13, 2020

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  • Active Ingredients

    Ethyl Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria that can potencially cause disease.

    For use when soap and water are not available.

  • WARNINGS

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

    DO NOT USE

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

    When using this product 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.

    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 surface. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • OTHER INFORMATION

    • Store between 15º - 30ºC (59-86F).
    • Avoid freezing and excessive heat above 40ºC (104F)
  • INACTIVE INGREDIENTS

    Glycerin, carbomer, triethanolamine, purified water USP, aloe vera.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76598-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76598-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    2NDC:76598-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    3NDC:76598-001-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    4NDC:76598-001-045000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    5NDC:76598-001-0520000 mL in 1 PACKAGE; Type 0: Not a Combination Product04/24/2020
    6NDC:76598-001-06200000 mL in 1 DRUM; Type 0: Not a Combination Product04/24/2020
    7NDC:76598-001-071000000 mL in 1 TANK; Type 0: Not a Combination Product04/24/2020
    8NDC:76598-001-084500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    9NDC:76598-001-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/24/2020
    Labeler - Bioagaves de la Costa, S.A. de C.V. (814644548)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bioagaves de la Costa, S.A. de C.V.814644548manufacture(76598-001)
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