SPL v3
SPL
SPL Set ID 33e56295-4edc-43fd-a937-1eeb32414fdb
Route
TOPICAL
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Cetearyl Ethylhexanoate Dimethicone Edetate Disodium Glycerin Palmitic Acid Polysorbate 20 Propylene Glycol Povidone, Unspecified Stearic Acid .alpha.-tocopherol Acetate Trolamine Ubidecarenone Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-08-01

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses
  • For the treatment of most athlete's foot (tinea pedis) or ringworm (tinea corporis).
  • For effective relief of redness, irritation, scaling, cracking, itching, burning feet.
Section 42229-5

Contents under pressure. Protect from heat and direct sunlight. Do  not puncture or incinerate. Do not store at temperatures above 120°F. If pregnant or breast feeding, ask a health professional before use.

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Section 50566-9

S top use and ask a doctor if

  • Irritation occurs or if there is no improvement within 4 weeks.
Section 50567-7

When using this product: • Avoid contact with the eyes. • Do not use on deep or puncture wounds, infections or lacerations.

Section 50570-1

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

Section 53413-1

Questions or comments? Call toll free 1-855-317-1107

Section 60561-8

For external use only

Warnings

Directions
  • Hold can upright. Shake well before each application.
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Water, Cetearyl ethylhexanoate, Butane, Propylene glycol, Palmitic acid, Propane, Stearic Acid, PVP, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl Acetate, Disodium EDTA, Ubiquinone

Principal Display Panel 125 G Can Label

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet



NET WT. 4.4 OZ (125g)


Structured Label Content

Uses
  • For the treatment of most athlete's foot (tinea pedis) or ringworm (tinea corporis).
  • For effective relief of redness, irritation, scaling, cracking, itching, burning feet.
Section 42229-5 (42229-5)

Contents under pressure. Protect from heat and direct sunlight. Do  not puncture or incinerate. Do not store at temperatures above 120°F. If pregnant or breast feeding, ask a health professional before use.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Section 50566-9 (50566-9)

S top use and ask a doctor if

  • Irritation occurs or if there is no improvement within 4 weeks.
Section 50567-7 (50567-7)

When using this product: • Avoid contact with the eyes. • Do not use on deep or puncture wounds, infections or lacerations.

Section 50570-1 (50570-1)

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

Section 53413-1 (53413-1)

Questions or comments? Call toll free 1-855-317-1107

Section 60561-8 (60561-8)

For external use only

Purpose

Antifungal

Warnings

Directions
  • Hold can upright. Shake well before each application.
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Active Ingredient (Active ingredient)

Clotrimazole 1%

Inactive Ingredients

Water, Cetearyl ethylhexanoate, Butane, Propylene glycol, Palmitic acid, Propane, Stearic Acid, PVP, Polysorbate-20, Triethanolamine, Glycerin, Dimethicone, Tocopheryl Acetate, Disodium EDTA, Ubiquinone

Principal Display Panel 125 G Can Label (PRINCIPAL DISPLAY PANEL - 125 g Can Label)

SKIN HYDRATING

TOPICAL FOAM

CLO-1

ANTIFUNGAL FOAM

Relief for itching

and burning feet



NET WT. 4.4 OZ (125g)


Advanced Ingredient Data


Raw Label Data

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