Label: FRESH PICKED STRAWBERRIES ANTI BACTERIAL HAND SANITIZER- benzethonium chloride liquid

  • 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 April 12, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzethonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    To decrease bacteria on the skin

  • WARNINGS

    For external use only

    When using this product: Keep out of eyes. Do not ingest.


  • ASK DOCTOR

    Stop use and ask a doctor if skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical assistance.

  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime size drop into hands
  • STORAGE AND HANDLING

    Other Information:

    • Do not store above 105F
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Deionized Water, Carbomer, Triehtanolamine, PEG-40 Hydrogenated Castor Oil, Fragrance, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

  • PRINCIPAL DISPLAY PANEL

    lablabel

  • INGREDIENTS AND APPEARANCE
    FRESH PICKED STRAWBERRIES ANTI BACTERIAL HAND SANITIZER  
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59021-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 82 g  in 100 mL
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59021-007-01225 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/12/2013
    Labeler - Five Below (095446659)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(59021-007)
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