Triple
FDA Label NDC 11086-021

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 11086-021). 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 active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

ZINC OXIDE 12.8%

Purpose

SKIN PROTECTANT

Uses

  • HELPS TREAT AND PREVENT DIAPER RASH
  • PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS

Warnings

FOR EXTERNAL USE ONLY

Otc - When Using

When using this product

  • DO NOT GET INTO EYES

Otc - Stop Use

Stop and ask a doctor if

  • condition worsens or does not improve within 7 days

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.

Directions

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow skin to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Inactive Ingredients

white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80.

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