Label: SUGAR COOKIES SCENTED ANTIBACTERIAL HAND SANITIZER- ethyl alcohol liquid

  • 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 9, 2010

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredients                        Purpose

    Ethyl Alcohol 62%                        Antiseptic

  • PURPOSE

    Uses

    To decrease bacteria on the skin that could cause disease

    Recommended for repeated use.

  • WARNINGS

    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

    Stop use and ask a doctor if skin irritation develops.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a poison control center immediately


  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands thoroughly with product and allow to dry without wiping

    For children under 6, use only under adult supervision

    Not recommended for infants.

  • INFORMATION FOR PATIENTS

    Other information

    Do not store above 105 degrees F

    May discolor some fabrics

    Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ingredients/ingredients: water (aqua), glycerin, trethanolamine, carbomer, fragrance (parfum), PEG-40, hydrogenated castor oil, DMCM Hydantoin, hydrogenated jojoba oil, FD and C blue No1, FD and C yellow No 5, FD and C red40

  • SPL UNCLASSIFIED SECTION

    Formulated exclusively and distributed by:
    Enchante Accessories, Inc.
    New York, NY 10016
    Not Tested On Animals. For adult use only.
    Designed in the USA
    Made in China
    3.1 fl oz/90 ml
  • PRINCIPAL DISPLAY PANEL

    Sugar Cookies

    scented

    Antibacterial

    Hand Sanitizer

    3.1 fl. oz. / 90ml

  • PRINCIPAL DISPLAY PANEL

    handsanitizerlabel
  • PRINCIPAL DISPLAY PANEL

    handsanitizerdrugpanel

  • INGREDIENTS AND APPEARANCE
    SUGAR COOKIES SCENTED ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-201
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-201-0190 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33307/07/2010
    Labeler - Enchante Accessories (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetic Co., Ltd.529047234manufacture
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