Resurfix Plus Ointment
FDA Label NDC 51326-884

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Resurfix Plus (NDC 51326-884). 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 other, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

  • For external use only, not to be swallowed.
  • Avoid contact with eyes.

Active Ingredients

Petrolatum U.S.P

Purpose

Skin protectant

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.

Warnings

  • Not to be applied over puncture wounds, infections, or lacerations.
  • If condition worsens or does not improve within 7 days, contact a physician.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Apply as directed by your physician.

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.

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)

Principal Display Panel (100 g Tube Label)

* Please review the disclaimer below.