Label: ALTRA ANTIMICROBIAL FOAMING HAND WASH WITH 0.3% PCMX- chloroxylenol solution

  • NDC Code(s): 30805-016-02, 30805-016-07
  • Packager: Buckeye International, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 April 21, 2020

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  • Active ingredient

    Chloroxylenol 0.3%

  • Purpose

    Antibacterial

  • Uses

    • Hand wash to help reduce bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only.

    When using this product do not use in or near eyes.

    If in eyes, flush thoroughly with water.

    If irritation or rash appears and persists, stop use and see a physician.

    Keep out of reach of children.

    If swallowed, call a physician or Poison control Center immediately.

  • Directions

    • Wet hands and wrists
    • Dispense an adequate amount of soap and vigorously wash hands
    • Rinse hands thoroughly
    • Dry hands completely
  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Coconut Acid C-110, Oleic Acid, Ammonium Laureth Sulfate, Ethanolamine, Cocamidopropyl Betaine, EDTA, Fragrance (Parfum), Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

  • Questions?

    Call Buckeye International, Inc. 314-291-1900

    Monday through Friday 8:00 a.m. to 5:00p.m. CST

  • PRINCIPAL DISPLAY PANEL

    ALTRA

    Antimicrobial Foaming

    Hand Wash

    with 0.3% PCMX

    Hand Hygiene

    Manufactured by:

    Buckeye International

    2700 Wagner Place Maryland Heights

    MO 63043 USA (314) 291-1900

    Product # 71031120

    net Contents 1250 mL (42.2 fl oz)

    container label

  • INGREDIENTS AND APPEARANCE
    ALTRA ANTIMICROBIAL FOAMING HAND WASH WITH 0.3% PCMX 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30805-016
    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
    COCONUT ACID (UNII: 40U37V505D)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30805-016-021250 mL in 1 BAG; Type 0: Not a Combination Product04/15/2020
    2NDC:30805-016-07550 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/2020
    Labeler - Buckeye International, Inc. (077132280)
    Establishment
    NameAddressID/FEIBusiness Operations
    Buckeye International, Inc.077132280manufacture(30805-016)
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