Otc - Active Ingredient
Active ingredient:
- Allantoin 0.5%
Bed Sore And Wound Healing Cream
FDA Label NDC 85384-0011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tagrid Llc for the product Bed Sore And Wound Healing Cream (NDC 85384-0011). 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, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
- Skin Protectant
Indications & Usage
Uses:
- Temporarily protects minor cuts, scrapes, and burns
- Helps relieve skin irritation associated with bed sores, pressure ulcers, or cracked skin
- Aids in the healing of wounds by forming a protective moisture barrier
Warnings
For external use only
Otc - Do Not Use
Do not use:
- On deep or puncture wounds
- On animal bites
- On serious burns
Otc - Ask Doctor
Ask a doctor before use if you have:
A serious wound or condition that requires medical attention
Otc - When Using
When using this product
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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
- You are allergic to any of the ingredients in this product
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding
Ask a health professional before use
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
Directions:
- Clean the affected area
- Apply a thin layer to the affected area 2 to 3 times daily or as directed by a physician
- May be covered with a sterile bandage or left uncovered
Other Safety Information
Other information:
- Store at 15°–30°C (59°–86°F)
- Avoid freezing and direct sunlight
- Tamper-evident: Do not use if seal under cap is broken or missing
Inactive Ingredient
Inactive ingredients:
- Colloidal Silver
- Water
- Tocopherol
- Madecassoside
- Centella Asiatica Whole
- Sodium Hyaluronate
- Honey
- Polysorbate 60
- Cetearyl Alcohol
- Mineral Oil
- White Petrolatum
- Glycerin
- Lavandula Angustifolia (Lavender) Oil
Otc - Questions
Questions or comments?
Contact us at [email protected]
Package Label.Principal Display Panel
Bedsorewoundhealingcream.jpg (Bedsorewoundhealingcream)
* Please review the disclaimer below.
