Triple
FDA Label NDC 11086-040

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Summers Laboratories Inc for the product Triple (NDC 11086-040). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

MICONAZOLE NITRATE 2%

Otc - Purpose

PURPOSE

ANTIFUNGAL

Indications & 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)

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks

Otc - Do Not Use

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

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

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

Dosage & 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

Inactive Ingredient

Inactive ingredients

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

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