Label: PEDESIL- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 7, 2012

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

View All Sections
  • 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 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 Pedesil 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, distilled water, eucalyptus citriodora oil, jojoba seed oil, silver oxide, tea tree oil, zinc oxide.


  • QUESTIONS

    Questions? 877-4-AIDANCE

  • PRINCIPAL DISPLAY PANEL - 28g Carton

    Carton Image

  • INGREDIENTS AND APPEARANCE
    PEDESIL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-303
    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)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-303-281 in 1 CARTON
    128 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-303) , label(24909-303)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!