Label: EPH LABS HAND SANITIZER- 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 27, 2020

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Inactive Ingredients

    Water, Carbomer Triethanolamine, Glycerin,Propylene Glycol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

  • Uses

    • To decrease bacteria and germs on skin • Recommended for repeated use.

  • Directions

    • Wet Hands throughly with product and allow to dry without wiping. • For children under 6, use only under adult supervision. • Not recommended for infants.

  • Warnings

    For external use only-hands. Flammable. Keep away from heat and flame.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Stop use and ask a doctor

    if skin irritation develops.

    When using this product:

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water. • Do not inhale or ingest. • Avoid contact with broken skin.

  • Other Information

    • Do not store above 105˚F
    • May discolour some fabrics
    • Harmful to wood finishes and plastics.

  • Package Labeling: 3786ml

    Label

  • Package Labeling: 1L

    Label2

  • Package Labeling: 300ml

    Label3

  • Package Labeling: 500ml

    Label4

  • INGREDIENTS AND APPEARANCE
    EPH LABS HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79759-002
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79759-002-013786 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    2NDC:79759-002-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    3NDC:79759-002-03300 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    4NDC:79759-002-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/10/2020
    Labeler - EPH Laboratories (099260755)