FDA Label for Dr Smiths Diaper

View Indications, Usage & Precautions

Dr Smiths Diaper Product Label

The following document was submitted to the FDA by the labeler of this product Mission Pharmacal. 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.

Otc - Active Ingredient



Active Ingredient

Zinc Oxide 10%


Otc - Purpose



Purpose

Skin Protectant


Indications & Usage



Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings



Warnings

For external use only


Otc - When Using



When using this product, avoid contact with the eyes.


Otc - Stop Use



See a doctor if condition lasts more than 7 days.


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Storage And Handling



Store between 15 0 and 30 0 C (59 0 and 86 0 F)


Inactive Ingredient



Inactive Ingredients

Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide


Other Safety Information



To report a serious adverse event of obtain product information, call (201)-696-8400


* Please review the disclaimer below.