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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51151-000
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (TOLNAFTATE)	TOLNAFTATE	1 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFOXIDE
GREEN TEA LEAF
ASCORBIC ACID
POVIDONE-IODINE
.ALPHA.-TOCOPHEROL ACETATE

Packaging
#	Item Code	Package Description
1	NDC:51151-000-01	1 BOTTLE (BOTTLE) in 1 CARTON
1		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/07/2012

Labeler - Pedicis Research LLC (078496974)

Establishment
Name	Address	ID/FEI	Operations
Pure Source Inc.		969241041	manufacture

Revised: 06/2012

Document Id: d384bb5a-4e76-4578-a7f0-9fc13c6559b9

Set id: bd53a9e3-65c8-4834-8e23-a2a928b83a66

Version: 2

Effective Time: 20120620

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

CIDACIN Antifungal Treatment

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