FDA.reportPublic FDA data

Dimethicone

Manufacturer
McKesson | Central Solutions
Effective date
2024-06-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:13:42

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 1.75%

OTC - PURPOSE SECTION

Purpose
Skin Protectant

INDICATIONS & USAGE SECTION

Uses

  • temporarily protects and helps relieve chapped or cracked skin
  • cleanses, moisturizes, and helps protect skin
  • it can be used on face, body and perineal area

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

  • Apply cleanser to damp cloth or to skin/ perineal area and then gently wipe clean
  • No rinsing necessary
  • Apply as needed
  • Apply a protectant cream as necessary

OTHER SAFETY INFORMATION

Store at 40-95ºF (4-35ºC)

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Alanine, Aleurites
Moluccana (Kukui) Seed Oil,
Aminomethyl Propanol, Arginine, Aspartic
Acid, Bisabolol, Butylene Glycol, Calcium
Pantothenate (Vitamin B5), Caprylyl
Glycol, Carthamus Tinctorius (Safflower)
Oleosomes, Carthamus Tinctorius
(Safflower) Seed Oil, Ceteareth-20, Cetyl
Alcohol, Chlorphenesin, Disodium EDTA,
Fragrance, Glutamic Acid, Glycerin,
Glyceryl Stearate, Glycine, Histidine,
Isoleucine, Isopropyl Myristate, Leucine,
Lysine, Maltodextrin, Niacinamide
(Vitamin B3), PEG-40 Sorbitan Peroleate,
Phenoxyethanol, Phenylalanine, Proline,
Pyridoxine HCL (Vitamin B6), Serine,
Silica, Sodium Ascorbyl Phosphate
(Vitamin C), Sodium Hyaluronate, Sodium
Starch Octenylsuccinate, Stearic Acid,
Threonine, Tocopheryl Acetate (Vitamin
E), Tyrosine, Valine, Water, Zingiber
Officinale (Ginger) Root Extract

OTC - QUESTIONS SECTION

Questions?
Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-0212-8
Thera
MOISTURIZING BODY CLEANSER
A no-rinse topical cleanser
Single Patient Use
NET CONTENTS 8 fl. oz (237 mL)
MFR # 53-MC8

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
68599-0212-8Dimethicone237 mg in 1 BOTTLELIQUID2375

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0212DIMETHICONE (BODY CLEANSER) LIQUID [MCKESSON]5Current NDC, Legacy NDC, 1 package rows20240616_8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8.zip

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-021268599-0212-8

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTENYLSUCCINIC ACID12UZE4X73LIACT
LEUCINEGMW67QNF9CIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER788QAG3W8AIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-40 SORBITAN PEROLEATE276639YRZLIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
WATER059QF0KO0RIACT
SAFFLOWER OIL65UEH262ISIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
ASPARTIC ACID30KYC7MIAIIACT
PROLINE9DLQ4CIU6VIACT
GLYCINETE7660XO1CIACT
TYROSINE42HK56048UIACT
PHENYLALANINE47E5O17Y3RIACT
ALANINEOF5P57N2ZXIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
SERINE452VLY9402IACT
VALINEHG18B9YRS7IACT
THREONINE2ZD004190SIACT
LYSINEK3Z4F929H6IACT
HISTIDINE4QD397987EIACT
ARGININE94ZLA3W45FIACT
GLUTAMIC ACID3KX376GY7LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
NIACINAMIDE25X51I8RD4IACT
GINGERC5529G5JPQIACT
KUKUI NUT OILTP11QR7B8RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MALTODEXTRIN7CVR7L4A2DIACT
ISOLEUCINE04Y7590D77IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
CALCIUM PANTOTHENATE568ET80C3DIACT

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 CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
ndc (package): 68599-0212-8
ndc (product): 68599-0212
ndc11 (package): 68599021208
spl id: 1adb3263-ed68-a5b1-e063-6394a90a7e45
spl set id: 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8

Reported adverse events (FAERS/openFDA)#

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