Label: 4-N-1 WASH- otc skin protectant drug product cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 17, 2020

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  • Active Ingredients:

    Dimethicone 1%

  • Purpose:

    Skin Protectant

  • Uses:

    • A gentle alternative to soap and water.
    •  Cleans, restores, nourishes, and protects even most delicate skin.
    •  Ideal for frequent cleansing and incontinence care.
  • Warnings:

    • For external use only.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Stop use and ask a doctor if – condition worsens or does not improve within 7 days; symptoms clear up and occur again within a few days.
    • Do not use on deep puncture wounds, animal bites, or serious burns.
  • Warnings:

    • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.
  • Directions:

    • For skin care: Apply quarter-sized amount to warm, damp cloth. Wash skin, turning the cloth as the skin is cleansed to remove residue.
    • For incontinence care: Remove excess fecal matter. Follow skin care directions above
  • Other Information:

    Store at room temperature (59°-86°F)

  • Ingredients:

    Butylparaben, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Ehtylparaben, Fragrance, Glyceryl Stearate, Isobutylparaben, Methyl paraben, PEG-100 Stearate, PEG-20 Glyceryl Stearate, Phenoxyethanol, Propylparaben, Water

  • 4-N-1 Wash Cream Package Label Principal Display Panel

    4-N-1 4oz

  • INGREDIENTS AND APPEARANCE
    4-N-1 WASH 
    otc skin protectant drug product cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-208-16452 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2010
    2NDC:61924-208-04113 g in 1 TUBE; Type 0: Not a Combination Product01/02/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/02/2010
    Labeler - DermaRite Industries, LLC (883925562)
    Registrant - DermaRite Industries, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaRite Industries, LLC883925562manufacture(61924-208)
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