FDA.reportPublic FDA data

Dimethicone

Manufacturer
McKesson | Central Solutions
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:27:30

Label at a glance#

ProductDimethicone
Active ingredientDIMETHICONE
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Dimethicone 5%

OTC - PURPOSE SECTION

Purpose
Skin Protectant

INDICATIONS & USAGE SECTION

Uses
for the treatment and/or prevention of diaper rash
temporarily protects and helps relieve chapped or cracked skin

WARNINGS SECTION

Warnings
For external use only.
When using this product

  • do not get into eyes

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser
  • Apply cream liberally until entire area is covered
  • Apply as needed

OTHER SAFETY INFORMATION


Store at 40-95ºF (4-35ºC)

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil,
Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil,
Dimethicone Crosspolymer, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3),
Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate,
Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,
Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance,
Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid,
Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine,
Tyrosine, Phenylalanine, Cysteine, Triethanolamine

OTC - QUESTIONS SECTION

Questions?
Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-0213-4
McKesson
Thera
DIMETHICONE BODY SHIELD
Provides mild skin protection against irritation from chapped or cracked skin.
Single Patient Use
NET CONTENTS 4 fl oz (118 mL)
MFR # 53-DS4

eacheach

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0213-4Dimethicone118 mg in 1 BOTTLECREAM1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0213DIMETHICONE (BODY SHIELD) CREAM [MCKESSON]4Current NDC, Legacy NDC, 1 package rows20241020_8febb45d-a200-702c-e053-2995a90a3e62.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-021368599-0213-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM PANTOTHENATE568ET80C3DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
OCTENYLSUCCINIC ACID12UZE4X73LIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
CAPRYLYL GLYCOL00YIU5438UIACT
PROLINE9DLQ4CIU6VIACT
GLYCINETE7660XO1CIACT
ARGININE94ZLA3W45FIACT
ASPARTIC ACID30KYC7MIAIIACT
ALANINEOF5P57N2ZXIACT
LEUCINEGMW67QNF9CIACT
TYROSINE42HK56048UIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MALTODEXTRIN7CVR7L4A2DIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GINGERC5529G5JPQIACT
LYSINEK3Z4F929H6IACT
THREONINE2ZD004190SIACT
GLUTAMIC ACID3KX376GY7LIACT
ISOLEUCINE04Y7590D77IACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
NIACINAMIDE25X51I8RD4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CHLORPHENESINI670DAL4SZIACT
HISTIDINE4QD397987EIACT
SERINE452VLY9402IACT
PHENOXYETHANOLHIE492ZZ3TIACT
LEVOMENOL24WE03BX2TIACT
DIMETHICONE92RU3N3Y1OACTIB
VALINEHG18B9YRS7IACT
PHENYLALANINE47E5O17Y3RIACT

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
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact identifier
ndc (package): 68599-0213-4
ndc (product): 68599-0213
ndc11 (package): 68599021304
spl id: 24c0a59c-1fad-f54e-e063-6394a90a5057
spl set id: 8febb45d-a200-702c-e053-2995a90a3e62

Reported adverse events (FAERS/openFDA)#

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