Label: GOURMET KITCHEN REGENERATING ANTI-BACTERIAL FRESH PICKED FIG- benzalkonium chloride lotion
GOURMET KITCHEN REGENERATING ANTI-BACTERIAL SWEET PLUM- benzalkonium chloride lotion

  • 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 December 7, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on hands.

  • Warnings

    For external use only.

    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 and ask a doctor if skin irritation develops.

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately.

  • Directions

    • Apply to hands thoroughly. Use daily or when needed to restore moisture and to decrease bacteria on skin.
  • Other information

    • Do not store above 105°F.
    • May discolor some fabrics.
    • Harmful to wood finishes and plastics.
    • You may report a serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903
  • Inactive ingredients

    Aqua (Water), Glycerin, Cetyl Alcohol, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, Dimethicone, Stearic Acid, Parfum (Fragrance), Althaea Officinalis Extract, Milk Lipid, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea Butter), Ethylhexyl Palmitate, Petrolatum, Polyethylene, Tocopheryl Acetate, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Carbomer, Sodium Hydroxide, Tetrasodium EDTA, Ultramarines. CONTAINS: Milk and Shea

  • PRINCIPAL DISPLAY PANEL - 255 mL Bottle Label

    time & again®

    REGENERATING
    ANTI-BACTERIAL
    hand cream

    fresh picked fig

    FORMULATED WITHOUT:
    PARABENS, FORMALDEHYDE
    RELEASING PRESERVATIVES

    CLEAN
    FORMULA

    8.6 fl oz (255 mL)

    PRINCIPAL DISPLAY PANEL - 255 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 255 mL Bottle Label

    time & again®

    REGENERATING
    ANTI-BACTERIAL
    hand cream

    sweet wild plum

    FORMULATED WITHOUT:
    PARABENS, FORMALDEHYDE
    RELEASING PRESERVATIVES

    CLEAN
    FORMULA

    8.6 fl oz (255 mL)

    PRINCIPAL DISPLAY PANEL - 255 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    GOURMET KITCHEN REGENERATING ANTI-BACTERIAL   FRESH PICKED FIG
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Althaea Officinalis Root (UNII: TRW2FUF47H)  
    Cow Milk Fat (UNII: 463JZS0XJ3)  
    Mangifera Indica Seed Butter (UNII: 4OXD9M35X2)  
    Shea Butter (UNII: K49155WL9Y)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Petrolatum (UNII: 4T6H12BN9U)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Sorbic Acid (UNII: X045WJ989B)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Ultramarine Blue (UNII: I39WR998BI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75862-019-01255 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E11/30/2011
    GOURMET KITCHEN REGENERATING ANTI-BACTERIAL   SWEET PLUM
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Althaea Officinalis Root (UNII: TRW2FUF47H)  
    Cow Milk Fat (UNII: 463JZS0XJ3)  
    Mangifera Indica Seed Butter (UNII: 4OXD9M35X2)  
    Shea Butter (UNII: K49155WL9Y)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Petrolatum (UNII: 4T6H12BN9U)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Sorbic Acid (UNII: X045WJ989B)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Ultramarine Blue (UNII: I39WR998BI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75862-023-01255 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E11/30/2011
    Labeler - GANZ U.S.A., LLC (798785242)
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