Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4cdfaaf0-a764-4393-b9c3-99b0d065eda7
Route
TOPICAL
Published
Effective Date 2014-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Bentonite Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide Tea Tree Oil White Wax Zinc Oxide Coconut Oil Glycerin Lauric Acid Lavender Oil Olive Oil Palm Acid Palm Kernel Acid Pentasodium Pentetate Propylene Glycol Sodium Stearate Shea Butter Sodium Laureth Sulfate Stearic Acid Sodium Chloride Sodium Palmate Sodium Palm Kernelate Sorbitol Titanium Dioxide Etidronate Tetrasodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-04-18

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses

Cures most fungal skin infections, including ringworm and tinea.

For effective relief of itching, scaling, cracking, burning, discoloration, soreness,

irritation, discomfort, redness and chafing associated with fungal skin infections.

Warnings

For external use only



Do not use on children under two years of age unless directed by a physician.

Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks,

discontinue use and consult a physician.

Directions

Ointment: Wash and dry affected skin.

Apply a thin layer of Terrasil over the affected area twice daily

(morning and night) or as directed by a doctor. Supervise children in the use of this product.

Store at room temperature. May stain fabrics.

Cleansing Bar: Wash affected area daily.

Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

Principal Display Panel Box

Anti-Fungal

  • Cures Most Fungal and Tinea Infections
  • Athlete's Foot, Jock Itch and Ringworm
  • Irritation, Burning and Discoloration

All Natural

terrasil

RAPID-CLEAR ANTI-FUNGAL OINTMENT

Plus Medicated Cleansing Bar

6X FASTER

compared to leading brands

in scientific studies

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

Keep Out of Reach of Children.

If swallowed, call poison control or seek medical help.


Structured Label Content

Uses

Cures most fungal skin infections, including ringworm and tinea.

For effective relief of itching, scaling, cracking, burning, discoloration, soreness,

irritation, discomfort, redness and chafing associated with fungal skin infections.

Purpose

Antifungal

Warnings

For external use only



Do not use on children under two years of age unless directed by a physician.

Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks,

discontinue use and consult a physician.

Directions

Ointment: Wash and dry affected skin.

Apply a thin layer of Terrasil over the affected area twice daily

(morning and night) or as directed by a doctor. Supervise children in the use of this product.

Store at room temperature. May stain fabrics.

Cleansing Bar: Wash affected area daily.

Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

Principal Display Panel Box (PRINCIPAL DISPLAY PANEL - BOX)

Anti-Fungal

  • Cures Most Fungal and Tinea Infections
  • Athlete's Foot, Jock Itch and Ringworm
  • Irritation, Burning and Discoloration

All Natural

terrasil

RAPID-CLEAR ANTI-FUNGAL OINTMENT

Plus Medicated Cleansing Bar

6X FASTER

compared to leading brands

in scientific studies

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call poison control or seek medical help.


Advanced Ingredient Data


Raw Label Data

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