Active Ingredient
Zinc oxide, 16%
Boudreauxs Butt Diaper Rash Original Cream
FDA Label NDC 63471-3002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geodis Logistics Llc for the product Boudreauxs Butt Diaper Rash Original (NDC 63471-3002). 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, when using this product, stop use and ask a doctor if, 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
Purpose
Skin protectant
Uses
- Helps treat and prevent diaper rash
- Protects chafed skin due to diaper rash and helps seal out wetness
Warnings
- For external use only
When Using This Product
- avoid contact with the eyes
Stop Use And Ask A Doctor If
- condition worsens or does not improve after 7 days
Keep Out Of Reach Of Children
- to prevent accidental ingestion
- If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately
Directions
- Change wet and soiled diaper immediately
- Cleanse the diaper area and allow to dry
- Apply ointment liberally and as often as neessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
Other Information
- Store at 15°C-25°C (59°F-77°F)
- Remove foil seal from tube's tip before use
- Use with infants, children and adults
- Will stain clothing and fabric
Inactive Ingredients
myroxylon pereirae (balsam peru) resin, mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil
Questions?
1-855-785-2888
www.buttpaste.com
Package Labeling:
Label2 (Label2)
* Please review the disclaimer below.
