Triple Paste Antifungal Ointment

Triple Paste Antifungal Ointment
SPL v3
SPL
SPL Set ID 9a47fb1b-a41f-4c8a-8e43-7332853c308e
Route
TOPICAL
Published
Effective Date 2021-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
White Petrolatum Starch, Corn Lanolin Stearyl Alcohol Yellow Wax Levomenol Cholesterol Water Glycerin Oat

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • For the treatment of superficial skin infections caused by yeast (Candida albicans)
  • Relieves discomfort, irrit.ation, redness and chafing associated with jock itch
  • Cures most jock itch (tinea cruris)
Section 42229-5

Drug Facts

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 productavoid contact with the eyes.

Section 50570-1

Do not use on childrenunder 2 years of age unless directed by a doctor.

Warnings

For external use only

Directions
  • Clean affected area and dry thoroughly
  • Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • Use daily for 2 weeks; If condition persists longer, consult a doctor
  • This product is not effective on the scalp or nails
Questions?

1-800-345-0032

Active Ingredient

Miconazole nitrate 2%

Other Information

Store at room temperature 15°– 30°C (59°– 86°F)

Inactive Ingredients

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 2 weeks
Principal Display Panel 56.7 G Tube Carton

Triple Paste AF ®

2% MICONAZOLE NITRATE ANTIFUNGAL OINTMENT

  • Relieves burning, redness,

    irritation and discomfort
  • Unique, soothing,

    water-resistant formula
  • Lubricates skin to heal

    and prevent chafing

Help is on the way...

Net Wt. 2 oz (56.7 g)


Structured Label Content

Uses
  • For the treatment of superficial skin infections caused by yeast (Candida albicans)
  • Relieves discomfort, irrit.ation, redness and chafing associated with jock itch
  • Cures most jock itch (tinea cruris)
Section 42229-5 (42229-5)

Drug Facts

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 productavoid contact with the eyes.

Section 50570-1 (50570-1)

Do not use on childrenunder 2 years of age unless directed by a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions
  • Clean affected area and dry thoroughly
  • Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • Use daily for 2 weeks; If condition persists longer, consult a doctor
  • This product is not effective on the scalp or nails
Questions?

1-800-345-0032

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Other Information (Other information)

Store at room temperature 15°– 30°C (59°– 86°F)

Inactive Ingredients (Inactive ingredients)

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 2 weeks
Principal Display Panel 56.7 G Tube Carton (PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton)

Triple Paste AF ®

2% MICONAZOLE NITRATE ANTIFUNGAL OINTMENT

  • Relieves burning, redness,

    irritation and discomfort
  • Unique, soothing,

    water-resistant formula
  • Lubricates skin to heal

    and prevent chafing

Help is on the way...

Net Wt. 2 oz (56.7 g)


Advanced Ingredient Data


Raw Label Data

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