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.

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Miracle Plus® Anti-Fungal

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

  • itching
  • scaling
  • cracking
  • burning
  • redness

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

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between toes; wear well-fitting ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks. If condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

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

  • Cures Most Athlete's Foot
    and Harmful Fungus
  • Relieves Itching, Cracking,
    Burning, Redness, Scaling
  • Beneficial Tea Tree, Aloe
    Vera and Vitamins A, C & E

2 FL OZ (59mL)

NDC 64058-615-12

Principal Display Panel - 59 mL Bottle Label
MIRACLE PLUS ANTI-FUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-615
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate0.59 g  in 59 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-615-1259 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/201103/09/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C01/04/201103/09/2013
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-615)

Revised: 2/2017
Document Id: 87731d7d-8573-4114-83b1-7009ca08e9ee
Set id: 65ed02fd-ddbf-4c8b-96db-4cb707938582
Version: 2
Effective Time: 20170206
 
Concept Laboratories, Inc.