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Product NDC Code | 53125-709 | ||||||
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Drug Name | Dermafoam premium antibacterial |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | SOAP | ||||||
RxCUI drug identifier | 1046593 | ||||||
Application Number | 505G(a)(3) | ||||||
Labeler Name | Superior Chemical Corporation | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Triclosan 0.30%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Antibacterial hand cleaner. Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial
Spl product data elements
Usually a list of ingredients in a drug product.DermaFoam Premium Antibacterial Benzalkonium Chloride WATER POTASSIUM COCOATE PROPYLENE GLYCOL GLYCERIN EDETATE SODIUM DMDM HYDANTOIN FD&C YELLOW NO. 5 ALOE VERA LEAF METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C RED NO. 40 BENZALKONIUM CHLORIDE BENZALKONIUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.75129-00_Derma Foam Premium Antibacterial 75129 Derma Foam
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Phone: (800) 777-9343 MDS information: (800) 891-4965
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 .
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API