Selan Antifungal

Selan Antifungal
SPL v9
SPL
SPL Set ID 8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29
Route
TOPICAL
Published
Effective Date 2013-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Propylene Glycol Water Methylparaben Propylparaben Diazolidinyl Urea Lanolin Dimethicone 1000 Zinc Oxide Polawax Polysorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-11-05

Description

Miconazole nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2%

Uses

 - Cures most jock itch (tinea cruris), ringworm (tinea corporis), athlete's foot (tinea pedis) and superficial yeast infections

 - Relieves itching, cracking, burning, redness, irritation and discomfort associated with these conditions

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation occurs or if there is no improvement

Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not use on children under 2 years old unless directed by a doctor

Warnings

For external use only

Directions

 - Clean affected area and dry thoroughly

 - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm)

 - Supervise children in the use of this product

For athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once daily

If condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.

Image of 4oz Tube

Other Information

store at room temperature

Active Ingredients

Miconazole nitrate 2%

Inactive Ingredients:

Dimethicone, emulsifying wax, fragrance, germaben II, lanolin, propylene glycol, water, zinc oxide


Structured Label Content

Uses

 - Cures most jock itch (tinea cruris), ringworm (tinea corporis), athlete's foot (tinea pedis) and superficial yeast infections

 - Relieves itching, cracking, burning, redness, irritation and discomfort associated with these conditions

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation occurs or if there is no improvement

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use on children under 2 years old unless directed by a doctor

Purpose

Antifungal

Warnings

For external use only

Directions

 - Clean affected area and dry thoroughly

 - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm)

 - Supervise children in the use of this product

For athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once daily

If condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.

Image of 4oz Tube (Image of 4oz tube)

Other Information (Other information)

store at room temperature

Active Ingredients

Miconazole nitrate 2%

Inactive Ingredients: (Inactive ingredients:)

Dimethicone, emulsifying wax, fragrance, germaben II, lanolin, propylene glycol, water, zinc oxide


Advanced Ingredient Data


Raw Label Data

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