Active Ingredients
Petrolatum 41%
Aquaphor
FDA Label NDC 54868-5870
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Aquaphor (NDC 54868-5870). 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, purpose, indications and usage, warnings, otc - when using, otc - do not use, otc - stop use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant ointment
Indications And Usage
Uses
• temporarily protects minor: • cuts • scrapes • burns
• temporarily protects and helps relieve chapped or cracked
skin and lips
• helps protect from the drying effects of wind and
cold weather
Directions Apply as needed
Warnings
For external use only
Otc - When Using
When using this product do not get into eyes
Otc - Do Not Use
Do not use on • deep or puncture wounds • animal bites
• serious burns
Otc - Stop Use
Stop use and ask a doctor if • condition worsens
• symptoms last more than 7 days or clear up and occur
again within a few days
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.
Inactive Ingredients
Mineral Oil, Ceresin, Lanolin Alcohol
Questions
Questions or comments? 1-800-227-4703
Directions
For the pharmacist: Aquaphor provides an ideal base for
compounding smooth, stable emulsions. It is highly miscible
with aqueous solutions and oil based substances.
Principal Display Panel
Aquaphor
OINTMENT
Skin Protectant
Ideal for Compounding
Dermatologist Recommended
SEVERELY DR Y SKIN TREATMENT
Clinically proven to restore smooth, healthy skin
NET WT
14 oz
396 g
Label (5870)
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
* Please review the disclaimer below.
