Summers Labs (as Pld) - Triple Paste Af (11086-040)

Summers Labs (as Pld) - Triple Paste Af (11086-040)
SPL v10
SPL
SPL Set ID 8d19b86d-b63c-485f-b143-2bc35f76c659
Route
TOPICAL
Published
Effective Date 2013-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Petrolatum Zinc Oxide Starch, Corn Lanolin Stearyl Alcohol Yellow Wax Cholesterol Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-30
Description

ACTIVE INGREDIENT MICONAZOLE NITRATE 2%

Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

Uses

  • For the treatment of superficial skin infections caused by yeast (Candida albicans).
  • Relieves discomfort, irritation, redness and chafing associated with jock itch
  • Cures most jock itch (tinea cruris)
Dosage and Administration

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
Description

ACTIVE INGREDIENT MICONAZOLE NITRATE 2%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks
Section 50567-7

When using this product avoid contact with eyes

Section 50570-1

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

Section 51727-6

Inactive ingredients

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol, polysorbate 80.

Section 51945-4

Section 55105-1

PURPOSE

ANTIFUNGAL

Section 55106-9

ACTIVE INGREDIENT

MICONAZOLE NITRATE 2%

Structured Label Content

Indications and Usage (34067-9)

Uses

  • For the treatment of superficial skin infections caused by yeast (Candida albicans).
  • Relieves discomfort, irritation, redness and chafing associated with jock itch
  • Cures most jock itch (tinea cruris)
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks
Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol, polysorbate 80.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

ANTIFUNGAL

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

MICONAZOLE NITRATE 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:20.874803 · Updated: 2026-03-14T23:01:22.645369