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CIDACIN Antifungal Treatment

Dosage form: solution
Ingredients: TOLNAFTATE 1mL in 100mL
Labeler: Pedicis Research LLC
NDC Code: 51151-000

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.

CIDACIN Antifungal Treatment

Drug Facts


Active Ingredient

Tolnaftate  1%

Purpose

Antifungal

Uses

For the cure of most ringworm (tinea orporis) and athletes foot (tinea pedis) fungal infections.  For the relief of itching; burning; scaling; cracking; redness; soreness; irritation; discomfort that may accompany fungal infections.

Warnings

For external use only.

Do not use

on children unless directed by a doctor.

When using this product

avoid eye contact.  If eye contact occurs, rinse thoroughly with water for 10-15 minutes.

Stop use and ask a doctor if
  •  if irritation occurs
  • no improvement is seen 4 weeks.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Consult a physician

before beginning treatment if pregnant/breast feeding.

Directions
  • Clean affected area with soap and water, rinse and dry thoroughly.
  • Apply to affected areas twice daily (morning and night) or as directed by physician.
  • Supervise children in the use of the product. 
  • For athlete's foot: Pay special attention to spaces between the toes.
  • For athlete's foot and ringworm:  Use daily for 4 weeks.  If condition persists longer, consult physician.
  • Formula will dry completely in several minutes without residue.
  • Change socks regularly at least once a daily.
  • Wear well-fitted, ventilated shoes.

Inactive ingredients

Dimethyl Sulfoxide (DMSO), Green Tea Extract, Ascorbic Acid (Vitamin C), Povidone Iodine, Vitamin E Acetate

Questions:

call 1-800-748-6539

PROFESSIONAL DISPENSED ONLY BY PHYSICIANS   CIDACIN Antifungal Treatment  PROFESSIONAL  Advanced Antifungal Solution  15mL / 0.5 oz  Distributed by  Pedicis Research LLC Radnor, PA 19087     Patent Pending

CIDACIN Antifungal Treatment 15ml (51151-000-01)

CIDACIN ANTIFUNGAL TREATMENT  
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51151-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL SULFOXIDE 
GREEN TEA LEAF 
ASCORBIC ACID 
POVIDONE-IODINE 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:51151-000-011 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/07/2012
Labeler - Pedicis Research LLC (078496974)
Establishment
NameAddressID/FEIOperations
Pure Source Inc.969241041manufacture

Revised: 06/2012
 
Pedicis Research LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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