FDA Label for Talc-free Medicated Body

View Indications, Usage & Precautions

Talc-free Medicated Body Product Label

The following document was submitted to the FDA by the labeler of this product Davion, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.