Active Ingredient
Petrolatum 41%
Aquasoothe Ointment
FDA Label NDC 67777-555
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Aquasoothe (NDC 67777-555). 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, stop use and ask a doctor if, do not use, keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
• Temporarily protects minor • cuts • scrapes • burns
• Temporarily protects and helps relieve chapped or cracked skin and lips
• Helps protect skin from the drying effects of wind and cold weather
Warnings
For external use only
Do not get into eyes
Stop Use And Ask A Doctor If
• Condition worsens
• Symptoms last more than 7 days or clear up and occur again with a few days
Do Not Use
• On deep or puncture wounds • Animal bites • Serious burns
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other Information
• Store at room temperature 15° - 30°C (59° - 86°F)
Directions
Apply as needed
Inactive Ingredients
ceresin wax, dexpanthenol, glycerin, lanoline alcohol, mineral oil
Questions?
1-888-DYNAREX Monday - Friday 9AM - 5PM EST
Label
1465_bx_master (1465 Bx Master R250908 1)
1464 Label
1463_in_master (1463 In Master R2500908 1)
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