Otc - Active Ingredient
Active Ingredient
Petrolatum 41.9%
Dimethicone 13.0%
Barrier Balm Ointment
FDA Label NDC 51514-0363
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp, Inc. for the product Barrier Balm (NDC 51514-0363). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, inactive ingredient, otc - questions, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent, temporarily protects and helps relieve chafed, chapped or cracked skin
Helps prevent and protect from the drying effects of wind and cold weather
Temporarily protects minor cuts, scrapes, burns
Indications & Usage
Directions
Apply as needed
Warnings
Warnings
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Do not use on deep or puncture wounds, animal bites, serious burns
When using this product do not get into eyes
Stop use and ask doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days
Inactive Ingredient
Caprylic/Capric triglyceride, Butyrospermum Parkii (Shea Butter), Aluminum Starch Octenylsuccinate, Synthetic Wax, Polyhydroxystearic Acid, Sodium Hyaluronate, Water, Zinc Oxide, Tocopheryl Acetate, Triethoxycaprylylsilane
Otc - Questions
Questions?
858-859-1188
Otc - 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
Dosage & Administration
Apply as needed
Package Label.Principal Display Panel
15g Tube Primary Container Image (Barrierbalm 15g Tube 1)
28g Tube Primary Artwork Image (Barrierbalm 28g Tube 1)
48g Tube Primary Artwork Image (Barrierbalm 48g Tube 1)
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