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

  • NDC Code(s): 24909-618-44
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • 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 July 22, 2012

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Allantoin 1%

    Benzethonium Chloride 0.2%

    Close
  • Purpose

    Allantoin - Skin Protectant

    Benzethonium Chloride - First Aid Antiseptic

    Close
  • 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.
    Close
  • 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.

    Close
  • 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.

    Close
  • Inactive Ingredients

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

    Close
  • SPL UNCLASSIFIED SECTION


    Made in USA. Distributed by Aspiera Medical, Woonsocket, RI 02895. (+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 Aspiera Medical.

    Close
  • PRINCIPAL DISPLAY PANEL - 44g Label

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

    Label Image

    Close
  • INGREDIENTS AND APPEARANCE
    ASPIERA WOUND CARE AND ANTISEPTIC 
    allantoin, benzethonium chloride ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-618
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 1 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24909-618-44 44 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 07/22/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    Name Address ID/FEI Business Operations
    Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-618) , label(24909-618)
    Close