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

  • NDC Code(s): 30805-010-02, 30805-010-05, 30805-010-07, 30805-010-09
  • 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 December 27, 2016

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.12%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

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

    Recommended for repeated use

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    Dispense an adequate amount of hand sanitizer

    Rub hands together until completely dry

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions?

    Call: Buckeye International, Inc. 314-291-1900

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

  • PRINCIPAL DISPLAY PANEL

    For General Hand Sanitizing

    Symmetry

    Non-Alcohol Foaming

    Hand Sanitizer

    w/ Allantoin and Aloe

    Product # 90153000

    Net Content  1000  ml (33.8 fl oz)

    container label

  • INGREDIENTS AND APPEARANCE
    SYMMETRY NON-ALCOHOL FOAMING HAND SANITIZER WITH ALLANTOIN AND ALOE  
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30805-010
    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
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Allantoin (UNII: 344S277G0Z)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30805-010-021250 mL in 1 BAG; Type 0: Not a Combination Product11/01/2011
    2NDC:30805-010-0550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2011
    3NDC:30805-010-07550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2011
    4NDC:30805-010-091000 mL in 1 BAG; Type 0: Not a Combination Product04/07/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2011
    Labeler - Buckeye International, Inc. (077132280)
    Establishment
    NameAddressID/FEIBusiness Operations
    Buckeye International, Inc.077132280manufacture(30805-010)
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