Label: PEDESIL MAXIMUM STRENGTH- clotrimazole ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 24909-301-28 - Packager: Aidance Skincare & Topical Solutions, LLC
- 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.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- STOP USE
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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
- Other Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 28g Carton
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INGREDIENTS AND APPEARANCE
PEDESIL MAXIMUM STRENGTH
clotrimazole ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1.0 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) EUCALYPTUS OIL (UNII: 2R04ONI662) JOJOBA OIL (UNII: 724GKU717M) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) SILVER OXIDE (UNII: 897WUN6G6T) TEA TREE OIL (UNII: VIF565UC2G) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-301-28 1 in 1 CARTON 1 28 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/07/2012 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-301) , label(24909-301)
