Otc - Active Ingredient
Active Ingredient
Triclosan 0.30%
Dermafoam Premium Antibacterial
FDA Label NDC 53125-709
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Superior Chemical Corporation for the product Dermafoam Premium Antibacterial (NDC 53125-709). 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, indications & usage, warnings, dosage & administration, inactive ingredient, otc - questions, otc - purpose, otc - 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
Indications & Usage
Uses
- Antibacterial hand cleaner.
- Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
Warnings
Warnings
- For external use only.
- Avoid contact with eyes.
- Children under the age of 6 should be supervised by an adult when using this product.
- Discontinue use is irritation or redness develops.
- If irritation persists for more than 72 hours, consult a physician.
- KEEP OUT OF REACH OF CHILDREN.
Dosage & Administration
Directions
- Read the entire label before using this product.
- Dispense 0.8 mL of product onto wet palm.
- Rub hands together to distribute product, then rinse hands with clean.
Inactive Ingredient
Inactive Ingredients
Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.
Otc - Questions
Questions or Comments?Phone: (800) 777-9343
MDS information:(800) 891-4965
Otc - Purpose
Purpose
Antibacterial
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
* Please review the disclaimer below.
