HEALTHY ACCENTS ATHLETES FOOT ANTIFUNGAL- tolnaftate cream 
DZA Brands LLC

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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DZA Brands, LLC Athlete's Foot Cream Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most
  • athlete’s foot (tinea pedis)
  • ringworm (tinea corporis)
  • helps prevent most athlete’s foot with daily use
  • for effective relief of
  • itching
  • burning
  • cracking

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use

on children under 2 years of age unless directed by a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot: pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • use daily for 4 weeks. If condition lasts longer, ask a doctor.
  • to prevent athlete’s foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Other information

store at 68°-77°F (20°-25°C)

Inactive ingredients

butylated hydroxytoluene, carbomer homopolymer type C, monoamylamine, PEG-400, propylene glycol, titanium dioxide

Questions or comments? 1-866-322-2439

Principal Display Panel

Compare to Tinactin® Antifungal Cream active ingredient

antifungal

athlete’s foot cream

relieves itching & burning

cures & prevents most athlete's foot

tolnaftate 1%

Athlete's Foot Cream Carton Image 1

Athlete's Foot Cream Carton Image 1

Athlete's Foot Cream Carton Image 2

Athlete's Foot Cream Carton Image 2

HEALTHY ACCENTS ATHLETES FOOT  ANTIFUNGAL
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55316-533
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CARBOMER HOMOPOLYMER TYPE C 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-533-641 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/21/2010
Labeler - DZA Brands LLC (090322194)

Revised: 7/2010
Document Id: ea3af4ff-d9c5-4c4d-b4da-c6a2f5cf0115
Set id: ea3af4ff-d9c5-4c4d-b4da-c6a2f5cf0115
Version: 1
Effective Time: 20100721
 
DZA Brands LLC