SPL v8
SPL
SPL Set ID 250d0a66-01d1-4aba-8f24-4cb4ca529fda
Route
TOPICAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Acetic Acid Benzyl Alcohol Isopropyl Alcohol Laureth-4 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-11

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes
Section 42229-5

Drug Facts

Warnings

For external use only

Directions
  • 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 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 scalp or nails.
Do Not Use

on children under 2 years of age unless directed by a doctor.

Flammable:

Do not use while smoking or near heat or flame.

Active Ingredient

Miconazole nitrate 2% USP

Other Information
  • store at controlled room temperature 15-30 oC (59-86 oF)
Inactive Ingredients

acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

Questions Or Comments?

1-800-321-4576

When Using This Product
  • avoid contact with the eyes.
  • if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
Keep Out of Reach of Children.

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

Fungoid Tincture – 1 Fl. Oz. (29.57 Ml) Carton

NDC0884-0293-01

PEDiNOL®

fungoid ®tincture

miconazole nitrate 2%

topical antifungal

1 fl. oz. (29.57 mL)


Structured Label Content

Uses
  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes
Section 42229-5 (42229-5)

Drug Facts

Purpose

Antifungal

Warnings

For external use only

Directions
  • 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 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 scalp or nails.
Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor.

Flammable:

Do not use while smoking or near heat or flame.

Active Ingredient (Active ingredient)

Miconazole nitrate 2% USP

Other Information (Other information)
  • store at controlled room temperature 15-30 oC (59-86 oF)
Inactive Ingredients (Inactive ingredients)

acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

Questions Or Comments? (Questions or comments?)

1-800-321-4576

When Using This Product (When using this product)
  • avoid contact with the eyes.
  • if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Fungoid Tincture – 1 Fl. Oz. (29.57 Ml) Carton (Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton)

NDC0884-0293-01

PEDiNOL®

fungoid ®tincture

miconazole nitrate 2%

topical antifungal

1 fl. oz. (29.57 mL)


Advanced Ingredient Data


Raw Label Data

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