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| Product NDC Code | 51326-884 | ||||
|---|---|---|---|---|---|
| Drug Name | Resurfix plus |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| Application Number | M016 | ||||
| Labeler Name | Topiderm, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Petrolatum U.S.P
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 Apply as directed by your physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Allantoin, Benzyl Alcohol, Camellia Sinensis (Green Tea) Leaf Extract, Ceramide 2, Ceramide-3, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Glycine Soja (Soybean) Seed Extract, Lanolin Alcohol, Mineral Oil, Palmitoyl Oligopeptide, Panthenol, PEG-10 Rapeseed Sterol, Phospholipids, Saccharomyces Lysate Extract, Sorbitan Isostearate, Squalane, Tocopheryl Acetate, Tribehenin, Yucca Glauca Root Extract, Water.
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 A unique dressing formulated to aid in the Skin Barrier healing process. Also provides protection and helps heal stressed skin conditions such as chapped, dry and windburned skin.
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Resurfix Plus Petrolatum PETROLATUM PETROLATUM ALLANTOIN BENZYL ALCOHOL GREEN TEA LEAF CERAMIDE NG CERAMIDE NP ALKYL (C12-15) BENZOATE ETHYLHEXYL PALMITATE SOYBEAN LANOLIN ALCOHOLS MINERAL OIL PALMITOYL TRIPEPTIDE-1 PANTHENOL PEG-10 RAPESEED STEROL LECITHIN, SOYBEAN SACCHAROMYCES LYSATE SORBITAN ISOSTEARATE SQUALANE .ALPHA.-TOCOPHEROL ACETATE TRIBEHENIN YUCCA GLAUCA ROOT WATER
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.PRINCIPAL DISPLAY PANEL - 100 g Tube Label REPLENiX ® RESURFIX + SKIN BARRIER HEALING OINTMENT SKIN PROTECTANT Post Aesthetic • Post Procedure • Post Treatment Ceramide 2 & 3 • LYCD Green Tea Extract • Squalane NF Panthenol • Vitamin E • Allantoin Petrolatum USP Net wt. 3.5 oz. (100 g.) Topix Pharmaceuticals, Inc. • N. Amityville, NY 11701 PRINCIPAL DISPLAY PANEL - 100 g Tube Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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 Not to be applied over puncture wounds, infections, or lacerations. If condition worsens or does not improve within 7 days, contact a physician. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. For external use only, not to be swallowed. Avoid contact with eyes.
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