Label: FIRST MARK ULTRA HAND SANITIZER- alcohol liquid

  • NDC Code(s): 51042-002-09
  • Packager: Performance Food Group
  • 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 November 14, 2022

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  • Active ingredient

    Ethyl Alcohol 60% v/v

  • Purpose

    Antiseptic handwash

  • Uses

    • For handwashing to decrease bacteria on the skin
  • Warnings

    • For external use only
    • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge

    Do not use

    • In eyes

    When using this product

    • If in eyes, rinse promptly and thoroughly with water
    • Discontinue use if irritation and redness develop

    Stop use and ask a doctor if eye or skin irritation or redness occurs for more than 72 hours

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

  • Directions

    • Apply liberal amount into hand
    • Spread by rubbing hands together
    • Rub to dryness with attention to area around nails and between fingers
  • Other information

    • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHINGWITH SOAP AND WATER
    • For additional information, see Safety Data Sheet (SDS)
    • EMERGENCY HEALTH INFORMATION: In the US, call (833) 571-1403
  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

  • Principal display panel and representative label

    REORDER # 644086

    1111219 778372

    778372/7300/0521

    FIRST

    MARK

    The Mark of Quality In 

    Non-Food Essentials

    ULTRA

    HAND

    SANITIZER

    Active Ingredient: Ethanol 60% by volume

    SDS-NC-872, SDS-NJ-20007

    40.6 US fl. oz. (1200 mL)

    Meets the requirements for

    Hand Antiseptics as specified

    in section 2-301.16 of the

    2017 Model Food Code.

    Made in the USA

    DISTRIBUTED BY:

    PERFORMANCE FOOD GROUP

    12500 WEST CREEK PARKWAY

    RICHMOND, VIRGINIA 23238

    representative label

  • INGREDIENTS AND APPEARANCE
    FIRST MARK ULTRA HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51042-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51042-002-091200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/21/2021
    Labeler - Performance Food Group (127038714)
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