Label: HANDS FIRST 4 IN 1- benzalkonium chloride, allantoin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 13, 2010

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  • ACTIVE INGREDIENT

    Allantoin 0.5%
    Benzalkonium Chloride 0.13%

    Skin Protectant

    Antimicrobial

    Use(s)

    For handwashing to decrease bacteria on the skin

    For temporary protection of minor cuts, scrapes, burns, and chapped or cracked skin

    Directions

    Use as needed

    Remove cap and pump foam into palm of hand.

    Rub foam onto hands

    Allow to air dry


    For external use only
    Keep out of the reach of children
    Do not use in the eyes
    Do not use on deep or puncture wounds, animal bites, or serious burns
    Extended use may increase risk of sunburn

    Stop use and ask a doctor if condition worsens or symptoms last more than seven days.

    Purified Water, tego-betaine, aloe vera, dimethicone, *collodial silver, glycolic acid, potassium hydroxide, EDTA, phenoxyethanol, isobutyl paraben, propyl paraben, ethyl paraben, butyl paraben, methyl paraben

    *Preservative only .1%

  • PRINCIPAL DISPLAY PANEL

    Hands First
    4 in 1 action
    Alcohol Free Foam
    Hand Sanitizer
    Doctor created and hospital tested
    Temporarily  protect minor cuts and scrapes
    Sanitize anytime, anywhere
    Hydrate your skin
    Clean without water

    Kills 99.99% of germs
    Attack Recontamination
    1.7 fl oz (50mL)

    MM2
    HF2.jpg
    image of bottle


  • INGREDIENTS AND APPEARANCE
    HANDS FIRST  4 IN 1
    benzalkonium chloride, allantoin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51098-742
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 g  in 1000 mL
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51098-742-02360 mL in 1 BOTTLE, PLASTIC
    2NDC:51098-742-0150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2010
    Labeler - Avadim II LLC (962520412)