60ba6f8a-8617-d4f6-e053-2991aa0a4a71

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

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

• cures most athlete’s foot infections and ringworm infections

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

accompany these conditions

Purpose

Antifungal

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
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

Description

Drug Facts

Principal Display Panel

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.

Active Ingredient

Clotrimazole 1%

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

Warnings

For external use only

Uses

• cures most athlete’s foot infections and ringworm infections

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

accompany these conditions

Purpose

Antifungal

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
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)

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.

Active Ingredient (Active ingredient)

Clotrimazole 1%

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

All Sections (JSON)