ProCure HydroShield
ProCure HydroShield is an FDA drug label for the active ingredient PETROLATUM 44.28% manufactured by Twin Med LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260803.
- Generic name
- PETROLATUM 44.28%
- Manufacturer
- Twin Med LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 55681-034
- Application
- M016
- Label effective
- 20260803
About this product
ProCure HydroShield is an FDA-registered drug product whose active ingredient is PETROLATUM 44.28%. It is labelled by Twin Med LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 55681-034, application M016, label effective 20260803. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing PETROLATUM 44.28% are most often described in connection with: temporarily protects, minor cuts, scrapes burns, helps relieve, chafed chapped, cracked skin, drying effects, cold weather. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Uses Temporarily protects minor: cuts, scrapes, burns Temporarily protects and helps relieve chafed, chapped or cracked skin and lips Helps protect from the drying effects of wind and cold weather
Dosage & Administration
Directions Directions: Apply as needed
Warnings
Warnings Warnings For external use only When using this product When using this product do not get into the eyes Stop use and ask a doctor if 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 Do not use on Do not use on deep or puncture wounds, animal bites, serious burns Keep out of reach of children Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away
Frequently asked questions
What is ProCure HydroShield used for?
Uses Uses Temporarily protects minor: cuts, scrapes, burns Temporarily protects and helps relieve chafed, chapped or cracked skin and lips Helps protect from the drying effects of wind and cold weather
Who makes ProCure HydroShield?
Twin Med LLC is the labeler of record for ProCure HydroShield.
What form does ProCure HydroShield come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is ProCure HydroShield prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has ProCure HydroShield been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.