Label: TENDERLAVEN HAND- chloroxylenol gel

  • NDC Code(s): 69771-006-10
  • Packager: Geri-Gentle Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.2%

    Purpose

    Antiseptic

  • Uses:

    For handwashing to decrease bacteria on the skin.

  • Warnings:

    Avoid contact with eyes. In case of contact, flush thoroughly with water. For external use only.

    Stop use:

    if irritation or redness develops.

    If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children

    except under adult supervision. In case of accidental ingestion contact a physician or Poison Control Center right away.

  • Directions:

    Wet hands and forearms. Apply 5 ml (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.

  • Other information:

    Store in a cool place away from direct sunlight.

  • Inactive ingredients:

    Water, sodium lauryl sulfate, Cocamide DEA, Cocamidopropyl Betaine, Glycerin, Citric Acid, Sodium chloride, Disodium EDTA, fragrance, Methylchloroisothiazolinone and Methylisothiazolinone, D&C Red NO.33, FD&C Blue NO.1

  • Package Labeling:

    Label2Label3

  • INGREDIENTS AND APPEARANCE
    TENDERLAVEN HAND 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-006-1010 in 1 CASE12/01/2020
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/2020
    Labeler - Geri-Gentle Corporation (080367686)
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