Label: ASPIERA WOUND CARE AND ANTISEPTIC- allantoin, benzethonium chloride ointment

  • 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 31, 2012

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  • Active Ingredient

    Allantoin 0.5%

    Benzethonium Chloride 0.1%

  • Purpose

    Allantoin - Skin Protectant

    Benzethonium Chloride - First Aid Antiseptic

  • Uses

    • Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips.
    • Topical antiseptic to help decrease the risk of skin infection.
  • Warnings

    For external use only.
    When using this product, do not get into eyes.
    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.
    Do not use on deep or puncture wounds, animal bites or serious burns.

    Keep out of reach of children.

    If swallowed, call poison control or seek medical help.

  • Directions

    Wash and dry affected skin. Apply a thin layer of Aspiera. Cover affected area with a clean bandage. Repeat procedure 1-3 times daily until skin improves. Store at room temperature.

  • Inactive Ingredients

    bentonite, cera alba (organic beeswax), magnesium oxide, peppermint oil, sage oil, silver oxide, simmondsia chinensis (jojoba) seed oil, zinc oxide

  • SPL UNCLASSIFIED SECTION


    Made in USA. Distributed by Aspiera Medical, a division of Aidance Skincare & Topical Solutions, LLC. (+1) 401-400-0047 www.aspiera.com
    Protected by US and international patents granted and pending. Aspiera™ and Faster Penetration for Faster Healing™ are trademarks of Aidance Skincare (C) 2012 Aidance Skincare.

  • PRINCIPAL DISPLAY PANEL - 44g Label

    Aspiera
    Wound Care and Antiseptic Ointment
    Faster Penetration for Faster Healing™

    Label Image

  • INGREDIENTS AND APPEARANCE
    ASPIERA WOUND CARE AND ANTISEPTIC 
    allantoin, benzethonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-617
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-617-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34705/31/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture, label
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