Label: ASSURED HAND SANITIZER WITH MOISTURIZERS- alcohol gel

  • 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 May 6, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients............................................................Purpose
    Ethyl Alcohol 62 percent.................................................Antiseptic

  • PURPOSE

    Uses: Helps decrease bacteria on skin. Recommended for repeated use.

  • WARNINGS

    Warnings
    For external use only.
    Flammable. Keep away from fire or flame. Do not apply around eyes.
  • WHEN USING

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

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    Directions: Pump as needed into your palms and thoroughly spread on both hands.

  • STORAGE AND HANDLING

    Other information: Store at 20 C 68 to 77 F. May discolor fabrics.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance.

  • PRINCIPAL DISPLAY PANEL

    Assured

    Instant Hand Sanitizer with Moisturizers

    Go Anywhere Clip!

    Kills 99.99 percent of Germs

    Vitamin e and aloe vera

    Same active ingredient as Purell Hand Sanitizer

    2fl oz 59.2mL

  • PRINCIPAL DISPLAY PANEL

    sanclip

  • INGREDIENTS AND APPEARANCE
    ASSURED HAND SANITIZER WITH MOISTURIZERS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1080
    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
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1080-159.2 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/06/2010
    Labeler - Greenbrier International, Inc (610322518)
    Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture
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