ASPIERA ANTI-FUNGAL (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

ASPIERA ANTI-FUNGAL (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-606-44
Set ID 3c0adc95-f8d3-4100-80d0-537bf92b56c0
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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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