Otc - Active Ingredient
Calendula Officinalis1X HPUS 1.5%
Hermon Bed Sore And Pressure Sore Cream
FDA Label NDC 85398-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Hermon Bed Sore And Pressure Sore Cream (NDC 85398-023). 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, dosage & administration, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Healing and minimizes recurrence
Dosage & Administration
Healing of wounds, sores
Support healing of chafling, minor burns and sunburn
Warnings
For external use only.
Otc - Do Not Use
if you are allergic to Calendula Officinalis or any of the inactive ingredients.
Otc - Ask Doctor
Ask a doctor before if if you have deep puncture wounds, animal bites or serious burns.
Otc - Stop Use
Stop use and ask a doctor if
- your condition worsens
- does not improve
- persists for more than 7 days, or occurs again after a few days.
Otc - When Using
avoid contact with eyes
Otc - Keep Out Of Reach Of Children
If swallowed, seek medical advice immediately or contact a Poison Control Center right away. (1-800-222-1222)
Indications & Usage
- Apply a thin layer to the affected area and massage gently as soon aspossible after minor injury.
- Apply 3 times a day or as needed SensitivityTest for New Users.
- Apply sparingly to small affected areas during the first 3 days.
- If no adverse reaction occurs, use as directed.
Inactive Ingredient
Lithospermum Erythrorhizon Root Extract, Aqua, Zinc Oxide, Panax Notoginseng Extract, Allantoin, Aloe Barbadensis Leaf Extract, Squalane,Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, 1,3-Butylene Glycol,Mineral Oil, Cetearyl Alcohol, Cetearyl Glucoside, Phellodendron Amurense Bark Extract, Beta-Glucan, Arnica Montana Flower Extract,Centella Asiatica Extract, Phenoxyethanol, Sodium Hyaluronate,Hydroxyacetophenone, 1,2-Hexanediol
Other Safety Information
Store at room temperature.
Otc - Questions
Package Label.Principal Display Panel
Package (Package)
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