THERA Dimethicone Body Shield

Manufacturer: McKesson Medical-Surgical Inc. | PureTek Corporation
Effective date: 2011-09-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:50:54

Label at a glance#

ProductTHERA Dimethicone Body Shield

Active ingredientDIMETHICONE

Label structure9 sections

Indications and uses

For the treatment and/or prevention of diaper rash Temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

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

Storage and handling

Protect from freezing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

For the treatment and/or prevention of diaper rash
Temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

deep or puncture wounds
animal bites
serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse skin with THERA^TM Moisturizing Body Cleanser or THERA^TM Foaming Body Cleanser
Apply cream liberally until entire area is covered
Apply as needed

Other information

STORAGE AND HANDLING SECTION

Protect from freezing. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Lead Juice, SAFFLEX^TM(Consisting of: 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)), Bisabolol, Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tintorius (Safflower) Seed Oil, Cetyl Alcohol, Chlorphenesin, Dimethicone Crosspolymer, Disodium EDTA, Glycerin, Glyceryl Stearate, Lavender Ylang Fragrance, PEG-100 Stearate, Pentaery Tetra-di-t-Butyl Hydroxyhydrocinnamate, Phenoxyethanol, Purified Water, Sodium Hyaluronate, Stearic Acid, Triethanolamine, Zingiber (Ginger) Root Extract.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of 4 fl oz label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Code 128	(01)10612479181301	GTIN-14: 10612479181301 GTIN storage (14 digits): 10612479181301	label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68599-0203-4	2020-07-10	C162847	48780-1	97431aae-1640-960c-e053-dbdaa90a7534	Drug Facts
68599-0203-4	2019-11-13	C162847	48780-1	97431aae-1640-960c-e053-dbdaa90a7534	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CALCIUM PANTOTHENATE	INACTIVE INGREDIENT	568ET80C3D	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
KUKUI NUT OIL	INACTIVE INGREDIENT	TP11QR7B8R	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

THERA Dimethicone Body Shield
Dimethicone
KUKUI NUT OIL
ALOE VERA LEAF
CALCIUM PANTOTHENATE
MALTODEXTRIN
NIACINAMIDE
PYRIDOXINE HYDROCHLORIDE
SILICON DIOXIDE
SODIUM ASCORBYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE, DL-
LEVOMENOL
BUTYLENE GLYCOL
CAPRYLYL GLYCOL
SAFFLOWER OIL
CETYL ALCOHOL
CHLORPHENESIN
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
PHENOXYETHANOL
WATER
HYALURONATE SODIUM
STEARIC ACID
TROLAMINE
GINGER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68599-0203	68599-0203-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
KUKUI NUT OIL	TP11QR7B8R	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CALCIUM PANTOTHENATE	568ET80C3D	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
NIACINAMIDE	25X51I8RD4	IACT
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM ASCORBYL PHOSPHATE	836SJG51DR	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
LEVOMENOL	24WE03BX2T	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
SAFFLOWER OIL	65UEH262IS	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
WATER	059QF0KO0R	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
GINGER	C5529G5JPQ	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 330 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SAFFLOWER OIL	SAFFLOWER OIL	65UEH262IS	LOTION / TOPICAL		3510 mg	Exact identifier — unii candidate
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a9ee0b7a-c6ab-5cc3-e053-2a95a90abce3			0ce3b82e-78a7-4398-a91d-4e8131926410	2020-07-08	Warnings	Exact identifier spl set id: 0ce3b82e-78a7-4398-a91d-4e8131926410

Reported adverse events (FAERS/openFDA)#

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