CIDACIN ANTIFUNGAL TREATMENT- tolnaftate solution

CIDACIN Antifungal Treatment by

Drug Labeling and Warnings

CIDACIN Antifungal Treatment by is a Otc medication manufactured, distributed, or labeled by Pedicis Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

CIDACIN ANTIFUNGAL TREATMENT 
tolnaftate solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POVIDONE-IODINE (UNII: 85H0HZU99M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51151-000-01	1 in 1 CARTON	02/05/2017
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

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)