Label: CUCUMBER MELON ANTIBACTERIAL SANITIZER- 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 25, 2010

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients.........................purpose

    Alcohol 62%.....................................antiseptic

  • WARNINGS

    Warning. For external use only-hands

    Flammable keep away from heat and flame

  • WHEN USING

    When using this product. keep out of eyes. In case of contact with eyes, flush thoroughly with water,

    do not inhale or ingest. avoid contact with broken skin.

  • STOP USE

    Stop use and ask a doctor if skin irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    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 with out wiping

    For children under 6, use only under adult supervision

    not recommended for infants.

  • PURPOSE

    Uses:

    To decrease germs on the skin

    recommended for repeated use.

  • INFORMATION FOR PATIENTS

    Other Information

    Do not store above 105oC

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (aqua), Alcohol, Peg-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Fragrance (parfum) Denatonium Benzoate. May contain FD and C Red No4 (CI14700), FD and C yellow No 5 (CI 19140), FD and C blue no1(CI42090), Dand C Red No 33 (CI17200)

  • SPL UNCLASSIFIED SECTION

    16fl oz/473 ml

  • PRINCIPAL DISPLAY PANEL

    goldessence bath and body collection

    cucumber melon
    Antibacterial Sanitizer 16floz / 473ml

  • PRINCIPAL DISPLAY PANEL

    cucmbermelonlabelpdp

  • PRINCIPAL DISPLAY PANEL

    cucumbermelon_panel1

  • INGREDIENTS AND APPEARANCE
    CUCUMBER MELON ANTIBACTERIAL SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51201-201
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51201-201-16473 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33307/25/2010
    Labeler - Goldessence, Limited (828132956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Nature Caring Products Co., Ltd.529296751manufacture
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