Your browser does not support JavaScript! PEDESIL (CLOTRIMAZOLE) CREAM [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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PEDESIL (clotrimazole) cream
[Aidance Skincare & Topical Solutions, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 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 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? 877-4-AIDANCE

PRINCIPAL DISPLAY PANEL - 28g Carton

Carton Image

PEDESIL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24909-303
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE 
EUCALYPTUS OIL 
JOJOBA OIL 
SILVER OXIDE 
TEA TREE OIL 
WATER 
ZINC OXIDE 
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)

Revised: 9/2012
 
Aidance Skincare & Topical Solutions, LLC

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