Label: ANTIBACTERIAL HAND SANITIZER- ethyl alcohol 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 January 1, 2023

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  • Antibacterial Hand Sanitizer

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • For Hand Sanitizing
  • Warnings

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

  • When using this product

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

  • Stop use and ask a doctor

    if skin irritation develops.

  • Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under the age of 6 use only under adult supervision.
    • Not recommended for infants.
  • Other Information

    • Do not store above 105°F.
    • May discolor some fabric.
  • Inactive Ingredients

    Water, Peg-6 AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Propylene Glycol, Glycerin, Fragrance, Aloe Barbedenis Leaf Juice.

  • DOSAGE & ADMINISTRATION

  • Principal Display Panel

    Peel here for continued Drug Facts
    Antibacterial Hand Sanitizer
    1 fl. oz.
    #94997 Hit® ASI-61125
    Sanitizer Made in the USA
    Hit Promotional Products Inc.
    Bellmawr, NJ
    Lot: XXXXX
    Exp. Date: XXXXX

    94997

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70204-513(NDC:65133-120)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70204-513-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/13/202008/31/2024
    2NDC:70204-513-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product08/13/202008/31/2024
    3NDC:70204-513-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/13/202008/31/2024
    4NDC:70204-513-04118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/202008/31/2024
    5NDC:70204-513-05237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/202008/31/2024
    6NDC:70204-513-06437 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/202008/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/13/202008/31/2024
    Labeler - Hit Promotional Products, Inc. (081070202)
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