ProCure Moisture Barrier

Manufacturer
Twin Med LLC
Effective date
2025-07-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:07:15

Label at a glance#

ProductProCure Moisture Barrier
Active ingredientZINC OXIDE, DIMETHICONE
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Dosage and administration

Directions Change wet and soiled diaper promptly Cleanse the diaper area, and allow to dry Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1% w/w

Zinc Oxide 12% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness.

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

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

  • Change wet and soiled diaper promptly
  • Cleanse the diaper area, and allow to dry
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Cholecalciferol, Chloroxylenol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCGDZ04 ImagePCGDZ04 Image

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-025-04ProCure Moisture Barrier113 g in 1 TUBECREAM1132

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-02555681-025-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

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 Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
ndc (package): 55681-025-04
ndc (product): 55681-025
ndc11 (package): 55681002504
spl id: 39eea0b7-df3d-a70e-e063-6294a90a19ea
spl set id: 3988c83b-d4eb-1f09-e063-6394a90a45ad

Reported adverse events (FAERS/openFDA)#

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