Label: CLOROX FRAGANZIA ANTIBACTERIAL HAND- chloroxylenol 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 September 22, 2020

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  • Active Ingredient

    Chloroxylenol 0.3%.

    Purpose

    Antibacterial

  • USE

    For handwashing to decrease bacteria on the skin.

  • Warning

    For external use only: hands only
    When using this product avoid contact with the eyes.
    If contact occurs, rinse eyes with water.
    Stop use and ask a doctor if irritation or redness
    develops- condition persists for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions Apply onto wet hands, lather for at least
    30 seconds and rinse thoroughly

  • Inactive ingredients

    WATER,SODIUM LAURETH SULFATE,COCAMIDOPROPYL
    BETAINE,GLYCERIN,COCAMIDE METHYL MEA,SODIUM
    CHLORIDE,PARFUM,CITRIC ACID,DISODIUM EDTA,
    METHYLCHLOROISOTHIAZOLINONE AND
    METHYLISOTHIAZOLINONE.

  • PRINCIPAL DISPLAY PANEL

    321

  • INGREDIENTS AND APPEARANCE
    CLOROX FRAGANZIA ANTIBACTERIAL HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77720-010-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    2NDC:77720-010-02296 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    3NDC:77720-010-03222 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    4NDC:77720-010-04237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    5NDC:77720-010-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    6NDC:77720-010-06355 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    7NDC:77720-010-07651 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    8NDC:77720-010-081006 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    9NDC:77720-010-09532 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    10NDC:77720-010-10118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/22/2020
    Labeler - Skaffles Group Limited Liability Company (831115642)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.,LTD.544493972manufacture(77720-010)
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