Label: PERIGIENE- antimicrobial drug product soap

  • NDC Code(s): 61924-198-01, 61924-198-08
  • Packager: Dermarite Industries LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Chloroxylenol 0.5%

  • Purpose:

    Antiseptic

  • Uses:

    • Antiseptic cleanser for use in the perineal area.
  • Warnings:

    • For external use only.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Ask a doctor before use if you have , deep of puncture wounds, animal bites, serious burns
    • When using this product, do not apply to areas of raw or blistered skin in large quantities, do not use in or near the eyes
    • Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days or clear up and recur within a few days
  • Warnings:

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

  • Directions:

    • Apply to perineal area.
    • Wipe with soft cloth.
    • Repeat as needed to clean the area.
  • Other information:

    Store at room temperature (59°-86°F). You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

  • Inactive Ingredients:

    Water, Sodium Lauryl sulfate, Sodium Laureth Sulfate, cocamide MEA, Cocamidopropyl Betaine, Polysorbate 20, Propylene glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Disodium EDTA, Sodium Isostearoyl Lactylate, Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Citric Acid, Sodium Hydroxide.

  • Question?

    Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

  • Perigiene Package Label Principal Display Panel

    PeriGiene

  • INGREDIENTS AND APPEARANCE
    PERIGIENE 
    antimicrobial drug product soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-198
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LEMON OIL (UNII: I9GRO824LL)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-198-08222 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/12/2011
    2NDC:61924-198-013800 mL in 1 JUG; Type 0: Not a Combination Product12/12/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/12/2011
    Labeler - Dermarite Industries LLC (883925562)
    Registrant - Dermarite Industries LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermarite Industries LLC883925562manufacture(61924-198)