Talc-free Medicated Body Powder
FDA Label NDC 42669-209

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Davion, Inc for the product Talc-free Medicated Body (NDC 42669-209). 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, warning, stop use and ask a doctor if, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 0.15%

Purpose

External Analgesic

Uses

Temporary relief of pain and itch associated with:

  • minor cuts
  • sunburn
  • insect bites
  • scrapes
  • minor burns
  • minor skin irritations

Warning

  • For external use only
  • Avoid contact with eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within few days

Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a poison control center right away.

Directions

Remove seal beneath cap before first use. Do not use if seal is broken or missing.

  • adults and children 2 years and older - apply freely upto 3 or 4 times daily
  • children under 2 years - ask a doctor

    • For best results, dry skin throughly before applying

Inactive Ingredients

Zea Mays (Corn) Starch, zinc oxide, Tricalcium Phosphate, Sodium Bicarbonate, salicylic acid, zinc stearate, Eucalyptus oil, Peppermint Oil

Principal Display Panel

NDC 42669-209-01

Compare to active ingredient in Gold Bond® Medicated Body Powder*

talc-free medicated body powder

triple relief formulahelps absorb moisture

helps soothe skin and relieves itching

NET WT 10oz (283 g)

Label (209)

Label (209)

* Please review the disclaimer below.