Label: PEDESIL MAXIMUM STRENGTH- clotrimazole ointment
- 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient
- 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.
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.Close
- STOP USE
Stop and use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.Close
- 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.
- Other Ingredients
Beeswax, Bentonite, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, Silver Oxide, Tea Tree Oil,Close
- PRINCIPAL DISPLAY PANEL - 28g Carton
- INGREDIENTS AND APPEARANCE
PEDESIL MAXIMUM STRENGTH
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24909-301 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 1.0 g in 100 g Inactive Ingredients Ingredient Name Strength BENTONITE EUCALYPTUS OIL JOJOBA OIL MAGNESIUM OXIDE SILVER OXIDE TEA TREE OIL WHITE WAX ZINC OXIDE 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)