DEFENSE ANTIFUNGAL MEDICATED BAR- tolnaftate soap

Defense Antifungal Medicated Bar by

Drug Labeling and Warnings

Defense Antifungal Medicated Bar by is a Otc medication manufactured, distributed, or labeled by Defense Soap LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• Proven clinically effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).
• For effective relief of itching, burning and cracking skin.

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 or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

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

• Wash affected area well and let product sit 1-2 minutes before rinsing.
• Make sure to dry affected area thoroughly.
• Supervise children in the use of this product.
• For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
• Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
• This product is not effective on the scalp or nails.

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, Charcoal Powder

Principal Display Panel

Tolnaftate 1%

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

DEFENSE SOAP Products are tested everyday in the toughest, dirtiest places in the world—the world of combat sports. Wrestlers, MMA fighters, and Jiu-Jitsu athletes are prone to getting fungal skin infections. It’s the nature of contact sports. These elite athletes use DEFENSE SOAP as part of their daily training regimen because they know it works. We use only the highest quality ingredients at full strength concentrations.

DEFENSE SOAP LLC, 13000 ATHENS AVE STE C313 LAKEWOOD, OH 44107 866-544-1689

INGREDIENTS AND APPEARANCE

DEFENSE ANTIFUNGAL MEDICATED BAR 
tolnaftate soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70856-3581
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 g

Inactive Ingredients
Ingredient Name	Strength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
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
Color	black	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70856-3581-2	1 in 1 CARTON	02/01/2019
1		119 g in 1 NOT APPLICABLE; 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	02/01/2019

Labeler - Defense Soap LLC (780587353)