FDA.reportPublic FDA data

Moisturizing body cream

Manufacturer
McKesson | Central Solutions
Effective date
2024-06-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:13:50

Label at a glance#

ProductDimethicone
Active ingredientDIMETHICONE
Label structure14 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
beneficial for face, hands, body and legs

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 cream liberally as needed

OTHER SAFETY INFORMATION

Store at 40-95ºF (4-35ºC).

INACTIVE INGREDIENT SECTION

Inactive ingredients
Alanine, Aleurites Moluccanus (Kukui) Seed Oil, Aloe
Barbadensis Leaf Juice, Arginine, Aspartic Acid, Bisabolol,
Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl
Glycol, Carthamus Tinctorius (Safflower) Oleosomes,
Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol,
Chlorphenesin, Dimethicone Crosspolymer, Dimethicone,
Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl
Stearate, Glycine, Histidine, Isoleucine, Leucine, Lysine,
Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate,
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), Triethanolamine, Tyrosine, Valine, Water, Zingiber
Officinale (Ginger) Root Extract

OTC - QUESTIONS SECTION

Questions?
Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68599-0218-4
McKesson
Thera
MOISTURIZING BODY CREAM
Everyday moisturizer and skin conditioner.
Single Patient Use
NET CONTENTS 4 fl oz (118 mL)
MFR # 53-CRM4
eacheach

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68599-0218-8
McKesson
Thera
MOISTURIZING BODY CREAM
Everyday moisturizer and skin conditioner.
Single Patient Use
NET CONTENTS 32 fl oz (946 mL)
MFR # 53-CRM32
eacheach

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68599-0218-1
McKesson
Thera
MOISTURIZING BODY CREAM
Refill for McKesson Pump Dispenser MFR # 53-1000.
NET CONTENTS 1000 mL (34 fl. oz.)
MFR # 53-CRM1000
eacheach

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148394dimethicone 1.75 % Topical CreamPSN4
1148394dimethicone 17.5 MG/ML Topical CreamSCD4
1148394dimethicone 1.75 % Topical CreamSY4

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
68599-0218-1Dimethicone1000 mg in 1 BAGCREAM10004
68599-0218-4Dimethicone118 mg in 1 TUBECREAM1184
68599-0218-8Dimethicone946 mg in 1 BOTTLECREAM9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0218DIMETHICONE (SKIN PROTECTANT) CREAM [MCKESSON]4Current NDC, Legacy NDC, 3 package rows20240619_96886b33-44d4-5a2a-e053-2a95a90a505e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68599-0218-4ML - Milliliter68599-0218b9394372-c923-4552-b1b6-a55b498a544012023-05-05

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-021868599-0218-4, 68599-0218-8, 68599-0218-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTENYLSUCCINIC ACID12UZE4X73LIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
LEVOMENOL24WE03BX2TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
EDETATE DISODIUM7FLD91C86KIACT
KUKUI NUT OILTP11QR7B8RIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
GINGERC5529G5JPQIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
ARGININE94ZLA3W45FIACT
ASPARTIC ACID30KYC7MIAIIACT
PROLINE9DLQ4CIU6VIACT
SERINE452VLY9402IACT
ALANINEOF5P57N2ZXIACT
GLYCERINPDC6A3C0OXIACT
PEG-100 STEARATEYD01N1999RIACT
CARTHAMUS TINCTORIUS FLOWER OILSDQ136WIM5IACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYALURONATE SODIUMYSE9PPT4THIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VALINEHG18B9YRS7IACT
ISOLEUCINE04Y7590D77IACT
PHENYLALANINE47E5O17Y3RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MALTODEXTRIN7CVR7L4A2DIACT
LYSINEK3Z4F929H6IACT
HISTIDINE4QD397987EIACT
GLUTAMIC ACID3KX376GY7LIACT
GLYCINETE7660XO1CIACT
LEUCINEGMW67QNF9CIACT
ALOE VERA LEAFZY81Z83H0XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
TYROSINE42HK56048UIACT

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
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
ndc (package): 68599-0218-1
ndc (package): 68599-0218-8
ndc (package): 68599-0218-4
ndc (product): 68599-0218
ndc11 (package): 68599021801
ndc11 (package): 68599021808
ndc11 (package): 68599021804
spl id: 1b2a2a80-2961-a52f-e063-6294a90a8c4d
spl set id: 96886b33-44d4-5a2a-e053-2a95a90a505e

Reported adverse events (FAERS/openFDA)#

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