Clotrimazole

Clotrimazole
SPL v4
SPL
SPL Set ID 24fef2d4-de93-2c29-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 mg)
Inactive Ingredients
Carthamus Tinctorius Flower Oil Mentha Piperita Simmondsia Chinensis Whole Emu Oil Olea Europaea Fruit Volatile Oil Almond Oil Urea Eucalyptus Globulus Whole Rosa Canina Flower Oil Water Butylated Hydroxytoluene Lavender Oil Melaleuca Alternifolia Whole Soybean Oil .alpha.-tocopherol Succinate, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-11-01

Description

clotrimazole 1%


Medication Information

Warnings and Precautions

For external use only

Ask a doctor before use on children under 2 years of age

When using this product avoid contact with eyes

Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

Indications and Usage

For the cure of most

• athlete’s foot (tinea pedis)

• ringworm (tinea corporis)

• jock itch (tinea cruris) For relief of

• itching • scaling • cracking • burning • redness • soreness • irritation

• discomforts which may accompany these conditions.

Dosage and Administration

• Use only as directed.

• Clean the affected area with soap and warm water and dry thoroughly.

• Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.

• This product is not effective on the scalp or nails.

• Avoid applying to severely cracked or irritated areas.

• For athlete’s foot: pay special attention to spaces between toes, wear well-fit- ting, ventilated shoes, and change shoes and socks at least once daily.

• For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily

for 2 weeks.

• Super vise children in the use of this product.

• Intended for use by normally healthy adults only.

• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.

Description

clotrimazole 1%

Section 50565-1

KE E P OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Aqua (Deionized Water), BHT, Car thamus Tinctorius (Saf flower) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycine Soja (Soybean) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea

Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopher yl Acetate (Vitamin- E), Urea.

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

clotrimazole 1%


Structured Label Content

Indications and Usage (34067-9)

For the cure of most

• athlete’s foot (tinea pedis)

• ringworm (tinea corporis)

• jock itch (tinea cruris) For relief of

• itching • scaling • cracking • burning • redness • soreness • irritation

• discomforts which may accompany these conditions.

Dosage and Administration (34068-7)

• Use only as directed.

• Clean the affected area with soap and warm water and dry thoroughly.

• Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.

• This product is not effective on the scalp or nails.

• Avoid applying to severely cracked or irritated areas.

• For athlete’s foot: pay special attention to spaces between toes, wear well-fit- ting, ventilated shoes, and change shoes and socks at least once daily.

• For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily

for 2 weeks.

• Super vise children in the use of this product.

• Intended for use by normally healthy adults only.

• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.

Warnings and Precautions (34071-1)

For external use only

Ask a doctor before use on children under 2 years of age

When using this product avoid contact with eyes

Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

Section 50565-1 (50565-1)

KE E P OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Aqua (Deionized Water), BHT, Car thamus Tinctorius (Saf flower) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycine Soja (Soybean) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea

Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopher yl Acetate (Vitamin- E), Urea.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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