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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24909-301
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 
MAGNESIUM OXIDE 
SILVER OXIDE 
TEA TREE OIL 
WHITE WAX 
ZINC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-301-281 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(24909-301), 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