Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e82e9521-6b0c-4b28-b64c-0cdfe97b320c
Route
TOPICAL
Published
Effective Date 2016-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 g)
Inactive Ingredients
Water Glycerin Dimethicone Oat C14-22 Alcohols Dicaprylyl Carbonate Sunflower Oil Polydextrose Polihexanide Hydrochloride Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Isohexadecane Polysorbate 60 Lavender Oil Carboxypolymethylene Phytate Sodium Eucalyptus Oil Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-05-04

Description

Clotrimazole USP 1%........................Antifungal

Purpose

Clotrimazole USP 1%........................Antifungal


Medication Information

Indications and Usage

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Purpose

Clotrimazole USP 1%........................Antifungal

Description

Clotrimazole USP 1%........................Antifungal

60g

120g

Uses
  • cures most athlete’s foot infections (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) infections
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Section 42229-5

Other Information  store between 20° - 25°C (68° - 77°F)

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.

Section 50570-1

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

Warnings

For external use only

Directions
  • Wash affected area and dry thoroughly
  • Spray a thin layer over 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 the toes, wear well-fitting, ventilated shoes and change socks at least once daily
  • For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor. This product is not effective on the scalp or nails
inactive Ingredients:

Aquaxyl, Dicaprylyl Carbonate, Dimethicone, Eucalyptus Oil, Glycerin, Lavender Oil, Montanov L, Oat Milk, Polyhexanide, Sepimax Zen, Simulgel INS100, Sodium Phytate, Sunflower Oil, Tea Tree Oil, Water

Active Ingredient/purpose

Clotrimazole USP 1%........................Antifungal


Structured Label Content

60g

120g

Uses
  • cures most athlete’s foot infections (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) infections
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Indications and Usage (34067-9)

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Section 42229-5 (42229-5)

Other Information  store between 20° - 25°C (68° - 77°F)

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.

Section 50570-1 (50570-1)

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

Warnings

For external use only

Directions
  • Wash affected area and dry thoroughly
  • Spray a thin layer over 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 the toes, wear well-fitting, ventilated shoes and change socks at least once daily
  • For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor. This product is not effective on the scalp or nails
inactive Ingredients: (Inactive ingredients:)

Aquaxyl, Dicaprylyl Carbonate, Dimethicone, Eucalyptus Oil, Glycerin, Lavender Oil, Montanov L, Oat Milk, Polyhexanide, Sepimax Zen, Simulgel INS100, Sodium Phytate, Sunflower Oil, Tea Tree Oil, Water

Active Ingredient/purpose (Active Ingredient/Purpose)

Clotrimazole USP 1%........................Antifungal


Advanced Ingredient Data


Raw Label Data

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