Label: HAND SANITIZER VANILLA SCENT- 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 September 24, 2014

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  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    • For hand washing to decrease bacteria on the skin
    • Recommended for repeated use.
  • Warnings

    • Flammable, keep away from fire or flame.
    • For external use only.
    • Do not use in the eyes. In case of contact with eyes, rinse thoroughly with water.
    • Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances.
    • Stop use and ask a doctor if irritation persists 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

    • Wet hands thoroughly with product and allow to dry without wiping.
    • Supervise children in the use of this product.
  • Other information

    • Store below 105 degrees F (40.5 degrees C).
    • May discolor some fabrics.
  • Inactive Ingredients

    • carbomer, DandC red n 33, FDandC blue n 1, FDandC yellow n 5, fragrance, glycerin, propylene glycol, triethanolamine, water
  • Product Labeling

    drug facts panel

    pdp



  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER VANILLA SCENT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60675-004
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60675-004-0030 mL in 1 BOTTLE
    2NDC:60675-004-0130 mL in 1 BOTTLE
    3NDC:60675-004-0230 mL in 1 BOTTLE
    4NDC:60675-004-0330 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/24/2014
    Labeler - Michaels Stores Procurement Company (030791425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huizhou Yiyani Cosmetic Limited421321809manufacture(60675-004)
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