Vitacilina Bebe Diaper Rash Ointment
FDA Label NDC 54312-525
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Compania Internacional De Comercio, S.a.p.i De C.v. for the product Vitacilina Bebe Diaper Rash (NDC 54312-525). 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 vitacilina bebé diaper rash ointment, active ingredients, purpose, uses, warnings, avoid contact, if condition, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Allantoin 1%
Zinc Oxide 25%
Purpose
Skin Protectant
Uses
• Treats and prevents diaper rash • Protects minor skin irritation associated with diaper rash • Helps seal out wetness
Warnings
For External use only
Avoid Contact
with the eyes
If Condition
worsens or does not improve within 7 days, consult a doctor
Keep Out Of The Reach Of Children
Directions
Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply ointment as often as necessary with each diaper change, specially at bedtime, or anytime when exposure to wet diapers may be prolonged
Inactive Ingredients
Petrolatum, Corn starch, fragrance, lanolin, methylparaben, mineral oil, propylparaben, vitamin A, vitamin D (calciferol)
Vitacilina Bebé Diaper Rash Ointment 50G (54312-525-16)
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