fungazoil advanced

fungazoil advanced
SPL v1
SPL
SPL Set ID babb5ca8-d608-4437-b35d-5133f7348d0c
Route
topical
Published
Effective Date 2014-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
clotrimazole (10 mg)
Inactive Ingredients
.alpha.-tocopherol water butylated hydroxytoluene safflower oil emu oil eucalyptus globulus leaf soybean oil lavender oil tea tree oil peppermint oil olive oil almond oil rosa canina fruit oil jojoba oil urea

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-06-15

Purpose

Antifungal

Description

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 as doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch) If swallowed, get medical help or contact a Poison control center immediately.


Medication Information

Warnings

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 as doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

If swallowed, get medical help or contact a Poison control center immediately.

Uses



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.

Purpose

Antifungal

Directions

Read all package directions and warnings before using.

• 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-fitting, 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.

Other Information

Apply to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.

Inactive Ingredients

Aqua (Deionized Water), BHT, Carthamus Tinctorius (Safflower) 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, Tocopheryl Acetate (Vitamin- E), Urea.

Description

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 as doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch) If swallowed, get medical help or contact a Poison control center immediately.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51945-4

Active Ingredient

Clotrimazole 1%


Structured Label Content

Warnings

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 as doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

If swallowed, get medical help or contact a Poison control center immediately.

Uses



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.

Purpose

Antifungal

Directions

Read all package directions and warnings before using.

• 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-fitting, 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.

Other Information

Apply to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), BHT, Carthamus Tinctorius (Safflower) 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, Tocopheryl Acetate (Vitamin- E), Urea.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51945-4 (51945-4)

Active Ingredient

Clotrimazole 1%


Advanced Ingredient Data


Raw Label Data

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