Label: PEARLESCENT- chloroxylenol soap

  • NDC Code(s): 57468-708-05
  • Packager: Boelter Companies Inc.
  • 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 July 29, 2020

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  • Pearlescent

    ​Active Ingredient

    Chloroxylenol 0.375%

  • Pearlescent

    Uses

    • ​​Antibacterial hand cleaner.
    • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
  • Pearlescent

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • Pearlescent

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 1-2 pumps of product onto wet palm.
    • Lather and rinse hands with clean water
  • Pearlescent

    Inactive Ingredients

    ​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

  • Pearlescent

    Purpose

    Antibacterial

  • Pearlescent

    KEEP OUT OF REACH OF CHILDREN

  • Pearlescent

    Boelter - 141

  • INGREDIENTS AND APPEARANCE
    PEARLESCENT 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57468-708
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRCENE (UNII: 3M39CZS25B)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    DIOXANE (UNII: J8A3S10O7S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
    ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    ETHYLENE OXIDE (UNII: JJH7GNN18P)  
    CHLOROACETIC ACID (UNII: 5GD84Y125G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57468-708-053780 mL in 1 JUG; Type 0: Not a Combination Product03/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/18/2013
    Labeler - Boelter Companies Inc. (006436299)
    Registrant - Betco corporation, Ltd. (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.024492831manufacture(57468-708) , pack(57468-708) , label(57468-708)
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