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

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%

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  • PURPOSE

    Purpose

    Antibacterial

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  • INDICATIONS & USAGE

    Uses

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

    Recommended for repeated use

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions

    Dispense an adequate amount of hand sanitizer

    Rub hands together until completely dry

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  • INACTIVE INGREDIENT

    Inactive ingredients

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

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  • QUESTIONS

    Questions?

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

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    SYMMETRY NON-ALCOHOL FOAMING HAND SANITIZER WITH ALLANTOIN AND ALOE  
    benzalkonium chloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:30805-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 0.12 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30805-010-02 1250 mL in 1 BAG; Type 0: Not a Combination Product 11/01/2011
    2 NDC:30805-010-05 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2011
    3 NDC:30805-010-07 550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2011
    4 NDC:30805-010-09 1000 mL in 1 BAG; Type 0: Not a Combination Product 04/07/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/01/2011
    Labeler - Buckeye International, Inc. (077132280)
    Establishment
    Name Address ID/FEI Business Operations
    Buckeye International, Inc. 077132280 manufacture(30805-010)
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