FDA.reportPublic FDA data

ProCure Skin Repair Cream

Manufacturer
Twin Med LLC
Effective date
2025-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:13:40

Label at a glance#

ProductProCure Skin Repair Cream
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure7 sections

Indications and uses

Uses Temporarily protects and helps relieve chafed, chapped or cracked skin Helps protect from the drying effects of wind and cold weather

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Uses

  • Temporarily protects and helps relieve chafed, chapped or cracked skin
  • 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 use near or 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

Apply as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Cetearyl Alcohol, Glycerin, Glyceryl Monostearate, Stearic Acid, PEG-100 Stearate, Carbomer, Olive Oil, Corn Oil, Canola Oil, Niacinamide, .Alpha.-Tocopherol Acetate, Vitamin A Palmitate, Cholecalciferol, Edetate Disodium, Aloe Vera Extract, Citrus Medica Limonum (Lemon) Peel Oil, Orange Oil, Cold Pressed, Lavender Oil, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol, Pyridoxine HCl, Fragrance, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCSR04PCSR04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309917dimethicone 1.5 % Topical CreamPSN1
309917dimethicone 15 MG/ML Topical CreamSCD1
309917dimethicone 1.5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-033-04ProCure Skin Repair Cream113 g in 1 TUBECREAM1131
55681-033-05ProCure Skin Repair Cream5 g in 1 PACKETCREAM51
55681-033-14ProCure Skin Repair Cream144 in 1 CARTONCREAM1441

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-03355681-033-04, 55681-033-05, 55681-033-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CORN OIL8470G57WFMIACT
PYRIDOXINE HCL68Y4CF58BVIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CHOLECALCIFEROL1C6V77QF41IACT
STEARIC ACID4ELV7Z65APIACT
PEG-100 STEARATEYD01N1999RIACT
OLIVE OIL6UYK2W1W1EIACT
NIACINAMIDE25X51I8RD4IACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CANOLA OIL331KBJ17RKIACT
LAVENDER OILZBP1YXW0H8IACT
FD&C RED NO. 40WZB9127XOAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
ndc (package): 55681-033-14
ndc (package): 55681-033-05
ndc (package): 55681-033-04
ndc (product): 55681-033
ndc11 (package): 55681003305
ndc11 (package): 55681003314
ndc11 (package): 55681003304
spl id: 3ba3d3b3-ab14-ea80-e063-6394a90ad459
spl set id: 3ba3d3b3-ab13-ea80-e063-6394a90ad459

Reported adverse events (FAERS/openFDA)#

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