Label: ASPIERA ANTI-FUNGAL- clotrimazole ointment

  • 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 July 22, 2012

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • Cures finger and toe area fungal infections.
    • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort and chafing associated with fungal infection.
  • Warnings

    For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes.

    Keep out of reach of children.

    If swallowed, call poison control or seek medical help.

  • STOP USE

    Stop and use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

  • Directions

    • For nail care, wash and dry affected skin. Apply a thin layer of Aspiera around and under entire nail and cuticle twice daily (morning and night) or as directed by a doctor.
    • If you see improvement within 4 weeks of use, you may continue use until satisfactory results are obtained.
    • For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks.
    • If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.
  • Other Information


    Store at room temperature.
  • Inactive Ingredients

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

  • 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.

  • PRINCIPAL DISPLAY PANEL - 44g Jar

    Aspiera

    Anti-Fungal Ointment

    Faster Penetration for Faster Healing™

    Label Image

  • INGREDIENTS AND APPEARANCE
    ASPIERA ANTI-FUNGAL 
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-606-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/31/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-606) , label(24909-606)
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