Label: HAND SANITIZER AVERY ESSENTIALS- ethyl 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 July 11, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl alcohol 70%.

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

    Flammable, keep away from fire or flame.For external use only.

    When using this product Avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor If redness or irritation develop and persist for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Spread on both hands, rub in, let dry.

  • INACTIVE INGREDIENT

     Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Fragrance.

  • Packaging

    123

    2364L60

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  AVERY ESSENTIALS
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78489-002
    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
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78489-002-20473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    2NDC:78489-002-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    3NDC:78489-002-404000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    4NDC:78489-002-23236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - UNIVERSAL CONSUMER BRANDS INC (246799600)