FDA.reportPublic FDA data

Active Ingredient

Manufacturer
Twin Med LLC
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-06 06:10:33

Label at a glance#

ProductProCure HydroShield
Active ingredientPETROLATUM
Label structure7 sections

Indications and 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 and administration

Directions: Apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Petrolatum 44.28%

Purpose

OTC - PURPOSE SECTION

Purpose: Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product do not get into the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

Do not use on deep or puncture wounds, animal bites, serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Mineral Oil, Microcrystalline Wax, Paraffin, Lanolin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCAC04 ImagePCAC04 Image

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10840330701300GTIN-14: 10840330701300
GTIN storage (14 digits): 10840330701300		PCAC04 Image.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-03455681-034-04, 55681-034-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
LANOLIN7EV65EAW6HIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-10-16full-release2026-06-01 01:39:18
12025-07-24full-release2026-06-01 01:13:40

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
ndc (package): 55681-034-04
ndc (package): 55681-034-16
ndc (product): 55681-034
ndc11 (package): 55681003416
ndc11 (package): 55681003404
spl id: 5828d726-ec07-e486-e063-6294a90a0ba1
spl set id: 3ab7bfb2-bbcf-0822-e063-6294a90af084

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.