SPL v4
SPL
SPL Set ID 60ba6f8a-8617-d4f6-e053-2991aa0a4a71
Route
TOPICAL
Published
Effective Date 2016-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Methyl L-arginine Olive Oil Panthenol Petrolatum Stearyl Alcohol Trolamine Urea Avocado Oil Sodium Hydroxymethylglycinate Titanium Dioxide Dimethicone 1000 Aloe Vera Leaf Shea Butter Glycerin Caprylic/capric/linoleic Triglyceride Water Cetyl Alcohol Hydrolyzed Jojoba Esters (acid Form) Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-02

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses

• cures most athlete’s foot infections and ringworm infections

• relieves itching, burning, cracking, scaling and discomfort which

accompany these conditions

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer to the 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 toes; wear well-fitting, ventilated shoes and change socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks
  • if condition persists longer, consult your doctor
  • this product is not effective on the scalp or nails
Active Ingredient

Clotrimazole 1%

Other Information

Store at controlled room temperature

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Fragrance, Glycerin, L-Arginine, Olea Europaea (Olive) Fruit Oil, Panthenol, Persia Gratissima (Avocado) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Esters, Stearic Acid, Stearyl Alcohol, Sodium Hydroxymethylglycinate, Titanium Dioxide, Triethanolamine, Urea (20%), Water

Principal Display Panel

Questions Or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

completely satisfied, please contact us directly for a full refund.

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks

Structured Label Content

Uses

• cures most athlete’s foot infections and ringworm infections

• relieves itching, burning, cracking, scaling and discomfort which

accompany these conditions

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer to the 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 toes; wear well-fitting, ventilated shoes and change socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks
  • if condition persists longer, consult your doctor
  • this product is not effective on the scalp or nails
Active Ingredient (Active ingredient)

Clotrimazole 1%

Other Information (Other information)

Store at controlled room temperature

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Fragrance, Glycerin, L-Arginine, Olea Europaea (Olive) Fruit Oil, Panthenol, Persia Gratissima (Avocado) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Esters, Stearic Acid, Stearyl Alcohol, Sodium Hydroxymethylglycinate, Titanium Dioxide, Triethanolamine, Urea (20%), Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions Or Suggestions? (Questions or Suggestions?)

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

completely satisfied, please contact us directly for a full refund.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks

Advanced Ingredient Data


Raw Label Data

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