Active Ingredients
White Petrolatum 66.2%....................Skin Protectant
Zinc Oxide 13.4%..............................Skin Protectant
Flanders Buttocks Ointment
FDA Label NDC 54323-215
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Flanders Inc for the product Flanders Buttocks (NDC 54323-215). 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 ingredients, uses, directions, keep out of reach of children, warnings, inactive ingredients, purpose, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps protect from wetness
Directions
- change wet and soiled diapers promptly, cleanse the diaper area, allow to dry
- apply ointment liberally as necessary, with each diaper change, especailly at bedtime or anytime prolonged exposure to wet diapers may be prolonged
Keep Out Of Reach Of Children
If swallowed, get medical help or call Poison Control Center right away.
Warnings
For External Use only
Do not Useover deep puncture wounds, infections, or lacerations.
When using this product avoid contact with eyes.
Stop use and ask a doctor if condition worsens or does not improve within 7 days
Inactive Ingredients
castor oil, light mineral oil, peruvian balsam, white beeswax
Purpose
Skin Protectant
Other Information
- store at room temperature
- Lot No. and Exp Date: see crimp of tube
- may stain clothing
Questions Or Comments
Call 1-855-NIX-RASH (1-855-649-7472)
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Active Ingredients/patient Education (20160328 094722 Resized)
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