Label: ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58575-512-01, 58575-512-02
  • Packager: Inopak, Ltd
  • 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 May 4, 2019

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

  • Active Ingredient

    Parachlorometaxylenol

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  • Purpose

    Antibacterial

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  • Use

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.
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  • Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
    • Stop use and ask a doctor if irritation or redness develop or if 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.
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  • Use

    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
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  • Stop Use

    • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
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  • Keep out of children's reach

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

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 minutes.
    • Rinse under running water and dry thoroughly.
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  • Inactive ingredients

    Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

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  • AmeriDerm Individual label

    NDC: 52410-8073-2

    AmeriDerm

    Foam Soap

    Antiseptic                            1000 ml

    Reorder No: 211                (33.8 fl. Oz.)

    Drug Facts

    Active Ingredient                                         Purpose

    Parachlorometaxylenol 0.3% w/w           Antiseptic

    Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.

    Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
    • Stop use and ask a doctor if irritation or redness develop or if 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

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 minutes.
    • Rinse under running water and dry thoroughly.

    Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

    AMO-80723                        Part# ALL-211                     Rev. 1.0

    Manufactured for:

    Shield Line LLC.

    Hackensack, NJ 07601

    USA

    www.ameriderm.com                   524 10 80723

    AmeriDerm individual label

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  • AmeriDerm Case label

    NDC: 52410-8073-2

    AmeriDerm

    Foam Soap

    Antiseptic                            1000 ml

    Reorder No: 211                (33.8 fl. Oz.)

    Drug Facts

    Active Ingredient                                         Purpose

    Parachlorometaxylenol 0.3% w/w           Antiseptic

    Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.

    Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
    • Stop use and ask a doctor if irritation or redness develop or if 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

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 minutes.
    • Rinse under running water and dry thoroughly.

    Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

    AMO-80723                        Part# ALL-211                     Rev. 1.0

    Manufactured for:

    Shield Line LLC.

    Hackensack, NJ 07601

    USA

    www.ameriderm.com                   524 10 80723

    REORDER NO:

    ALL-211                AMD-80723

    FOAMSOAP ANTISEPTIC                                AmeriDerm

    Wt:         1000ml (33.8 FL OZ)

    Qty:       6 Pouches

    Manufactured for: Shield Line LLC, Hackensack, NJ 07601 • Made in USA                20-80723AD-02

    1 03 52410 80723 4                         UOM: CS

    211-CS

    Rev. 1.0

    1000 ML PER

              POUCH

    6        POUCHES

              PER CASE

    AmeriDerm Case label

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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58575-512
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58575-512-01 1000 mL in 1 POUCH; Type 0: Not a Combination Product 01/01/2018
    2 NDC:58575-512-02 6000 mL in 1 CASE; Type 0: Not a Combination Product 01/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2018
    Labeler - Inopak, Ltd (194718243)
    Establishment
    Name Address ID/FEI Business Operations
    Inopak, Ltd 194718243 manufacture(58575-512)
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