MIRACLE PLUS ANTI-FUNGAL- tolnaftate cream 
Concept Laboratories, Inc.

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.

----------

Miracle Plus® Anti-Fungal

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

for effective treatment of most athlete's foot (tinea pedis)   Relieves

Warnings

For external use only.

  • do not use on children under 2 years of age unless directed by a doctor

  • if pregnant or nursing, seek the advice of a health professional before using

When using this product avoid contact with the eyes

  • if contact occurs rinse thoroughly with water

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water (Aqua), Glyceryl Stearate SE, Glycerin, Ceteareth 20, Mineral Oil, Cetearyl Alcohol, Propylene Glycol, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Dimethicone, Titanium Dioxide, Retinyl Palmitate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance.

Questions or comments?

Call 1-888-373-8831 or www.conceptlabs.org

Manufactured by Concept Laboratories, Inc.
Chicago, IL 60642 (USA)

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

MIRACLE
PLUS®

TOLNAFTATE 1%
Anti-Fungal
Foot Relief

ATHLETE'S FOOT CREAM

2 FL OZ (59mL)

NDC 64058-615-12

Principal Display Panel - 59 mL Bottle Label
MIRACLE PLUS ANTI-FUNGAL 
tolnaftate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-615
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate 0.59 g  in 59 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
TEA TREE OIL (UNII: VIF565UC2G)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64058-615-12 59 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333C 01/04/2011
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
Name Address ID/FEI Business Operations
Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-615)

Revised: 4/2013
Document Id: 5787ad93-5189-46d3-908c-aa4d613ccae0
Set id: 65ed02fd-ddbf-4c8b-96db-4cb707938582
Version: 1
Effective Time: 20130412
 
Concept Laboratories, Inc.