Procure Dimethicone 5%

Manufacturer
Twin Med LLC
Effective date
2025-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:05:55

Label at a glance#

ProductProcure Dimethicone 5%
Active ingredientDIMETHICONE
Label structure7 sections

Indications and uses

Uses temporaily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of whine and cold weather helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness

Dosage and administration

Directions As a skin protectan t apply as needed As a diaper cream 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, expecially at bedtime or anytime when exposure to wet diaper may be prolonged

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Uses

  • temporaily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of whine and cold weather
  • 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 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

As a skin protectant apply as needed

As a diaper cream

  • 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, expecially at bedtime or anytime when exposure to wet diaper may be prolonged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, .Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCGD004 ImagePCGD004 Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259090dimethicone 5 % Topical CreamPSN1
259090dimethicone 50 MG/ML Topical CreamSCD1
259090dimethicone 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
55681-024-04Procure Dimethicone 5%113 g in 1 TUBECREAM1131
55681-024-05Procure Dimethicone 5%5 g in 1 PACKETCREAM51
55681-024-14Procure Dimethicone 5%144 in 1 CARTONCREAM1441

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-02455681-024-04, 55681-024-05, 55681-024-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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 Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
ndc (package): 55681-024-14
ndc (package): 55681-024-05
ndc (package): 55681-024-04
ndc (product): 55681-024
ndc11 (package): 55681002404
ndc11 (package): 55681002414
ndc11 (package): 55681002405
spl id: 38a7e4af-997e-549e-e063-6394a90a0bd6
spl set id: 38a7e4af-997d-549e-e063-6394a90a0bd6

Reported adverse events (FAERS/openFDA)#

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