Otc - Active Ingredient
Active Ingredient
Zinc Oxide 10%
Dr Smiths Diaper
FDA Label NDC 71269-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mainpointe Pharmaceuticals, Llc for the product Dr Smiths Diaper (NDC 71269-006). 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 - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (502)709-7544.
* Please review the disclaimer below.
