Label: ALTRA NON-ALCOHOL FOAMING HAND SANITIZER WITH ALLANTOIN AND ALOE- benzalkonium chloride solution

  • NDC Code(s): 30805-015-02, 30805-015-05, 30805-015-07, 30805-015-09
  • Packager: Buckeye International, 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 April 15, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.12%

  • Purpose

    Antibacterial

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease
    • 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

    • Dispense an adequate amount of hand sanitizer
    • Rub hads together until completely dry
  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Allantoin, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone

  • Questions?

    Call Buckeye International, Inc. 314-291-1900

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

  • PRINCIPAL DISPLAY PANEL

    ALTRA

    Non-Alcohol

    Foaming hand

    Sanitizer

    with Allantoin and Aloe

    Hand Hygiene

    Manufactured by

    Buckeye International

    2700 Wagner Place Maryland Heights

    MO 63043 USA (314) 291-1900

    Product # 71151120

    Net Contents 1250 mL (42.2 fl oz)

    container label

  • INGREDIENTS AND APPEARANCE
    ALTRA NON-ALCOHOL FOAMING HAND SANITIZER WITH ALLANTOIN AND ALOE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30805-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30805-015-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    2NDC:30805-015-07550 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    3NDC:30805-015-091000 mL in 1 BAG; Type 0: Not a Combination Product04/15/2020
    4NDC:30805-015-021250 mL in 1 BAG; 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(30805-015)
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