DEFENSE ANTIFUNGAL MEDICATED BAR- tolnaftate soap 
Defense Soap 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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Defense Antifungal Medicated Bar

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

When using this product

When using this product avoid contact with the eye

Stop use and ask a doctor if

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use

Do Not use on children under 2 under of age except under the advice and supervision of a doctor.

Keep out of reach of children.

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

Directions

Other information

Store between 20 to 25C (68 to 77F)

Inactive ingredients

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid

Questions or comments?

1-866-544-1689

www.DefenseSoap.com

Principal Display Panel

Tolnaftate 1%

Antifungal
Medicated Bar Soap
Cures and Prevents Most Fungal Skin Infections, Including Athlete’s Foot, Ringworm and Tinea Versicolor.

External box

DEFENSE ANTIFUNGAL MEDICATED BAR 
tolnaftate soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70856-3434
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
WATER (UNII: 059QF0KO0R)  
SODIUM PALMATE (UNII: S0A6004K3Z)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
GLYCERIN (UNII: PDC6A3C0OX)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
PALM ACID (UNII: B6G0Y5Z616)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PALM KERNEL ACID (UNII: 79P21R4317)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70856-3434-31 in 1 CARTON08/01/2016
1119 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/01/2016
Labeler - Defense Soap LLC (780587353)

Revised: 11/2017
Document Id: 5f26fb54-0f5d-0107-e053-2a91aa0a359a
Set id: 38fd2c97-cd43-2f7d-e054-00144ff8d46c
Version: 2
Effective Time: 20171129
 
Defense Soap LLC