Defense Antifungal Medicated Bar

Defense Antifungal Medicated Bar
SPL v7
SPL
SPL Set ID 812d78ea-a14a-e3a2-e053-2a91aa0a6ff5
Route
TOPICAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Tetrasodium Glutamate Diacetate Eucalyptus Oil Water Sodium Gluconate Sodium Palm Kernelate Glycerin Melaleuca Alternifolia Leaf Sodium Chloride Activated Charcoal Sodium Palmate Sodium Cocoate

Identifiers & Packaging

Pill Appearance
Color: black
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-01

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

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

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.
Do Not Use

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

Active Ingredient

Tolnaftate 1%

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 LLC, 3390 LIBERTY ATHENS AVE VERMILLION, OH 44089 866-544-1689

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.

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.


Structured Label Content

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.
Purpose

Antifungal

Warnings

For external use only

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.
Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

Tolnaftate 1%

Inactive Ingredients (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 LLC, 3390 LIBERTY ATHENS AVE VERMILLION, OH 44089 866-544-1689

When Using This Product (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)

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.

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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