Label: 1438 DYNASOAP- antibacterial hand soap soap

  • 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 13, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13%.......Antiseptic handwash

  • Purpose

    Antibacterial Hand Soap

  • Use

    Cleaning and antiseptic cleansing of hands and skin.

  • Warnings

    For external use only.

    When using this product

    Avoid contact with eyes. In case of contact, flush with water.

    Stop use and ask a doctor if.

    Irritation and redness develop.

    Keep out of reach of children.

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

  • Directions.

    Wet hands and forearms. Apply 5 millileters (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 1 minute. Rinse and repeat.

  • Inactive Ingredients

    Benzyl Alcohol, Citric Acid Monohydrate, Cocamide DEA, Cocamidopropyl Betaine, Glycerin, Lauryl Glucoside, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Sulisobenzone, Water.

  • Label

    1438 DynaSoap Label1438 DynaSoap Label

  • INGREDIENTS AND APPEARANCE
    1438 DYNASOAP 
    antibacterial hand soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-319-0124 in 1 CASE08/01/2020
    10.13 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hobi Kozmetic Imalat Sanayi Ve Ticaret Anonim Sirketi533139227manufacture(67777-319)