Label: LEMON DROP GENTLE ANTISEPTIC- chloroxylenol liquid

  • NDC Code(s): 11429-1006-1, 11429-1006-2, 11429-1006-3, 11429-1006-4, view more
    11429-1006-5
  • Packager: Woodbine Products Company
  • 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 June 27, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Choroxylenol 0.3%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses:

    For hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings:

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

    If swallowed, get medical help or contact a Poison control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply to hands, add small amount of water and lather.

    Work until soil is emulsified, rinse and wipe dry.

  • STORAGE AND HANDLING

    Other Information:

    Store at 20 to 25 C (68 to 77 F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Propylene Glycol, Sodium Chloride, Fragrance and Glycerin.

  • PRINCIPAL DISPLAY PANEL

    PK

    Lemon Drop

    gentle lotion soap

    antiseptic

    Woodbine Products Company

    915 West Smith Road

    Medina, OH 44256

    Made in USA

    Stock # 245

    3.78 Liters (1 Gallon)

    container label

  • INGREDIENTS AND APPEARANCE
    LEMON DROP GENTLE ANTISEPTIC 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1006-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2014
    2NDC:11429-1006-2800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2014
    3NDC:11429-1006-42125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2014
    4NDC:11429-1006-53785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2014
    5NDC:11429-1006-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/16/2014
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1006)
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