PEDESIL MAXIMUM STRENGTH- clotrimazole ointment 
Aidance Skincare & Topical Solutions, LLC

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.

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Drug Facts

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses


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 and use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Directions

Other Information


Store at room temperature.

Other Ingredients

Beeswax, Bentonite, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, Silver Oxide, Tea Tree Oil,
Zinc Oxide.

Questions? 877-4-AIDANCE

PRINCIPAL DISPLAY PANEL - 28g Carton

Carton Image

PEDESIL  MAXIMUM STRENGTH
clotrimazole ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-301
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 9/2012
Document Id: c47bc18c-aa68-4df2-8eeb-c9daa67f19e6
Set id: e415c1b8-0cda-4626-b4d0-199ab34d3177
Version: 3
Effective Time: 20120907
 
Aidance Skincare & Topical Solutions, LLC