Zinc Oxide and Dimethicone

Manufacturer: Galentic Pharma (India) Private Limited
Effective date: 2013-08-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:36:30

Label at a glance#

ProductZinc Oxide and Dimethicone with Dimethicone

Active ingredientZINC OXIDE, DIMETHICONE

Label structure11 sections

Indications and uses

Indications are for diaper rash and general skin protectant.

Dosage and administration

For diaper rash change wet and soiled diapers promptly cleanse the diaper area and allow to dry Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged For poison ivy, oak and sumac apply ointment liberally as often as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient        Purpose
Zinc Oxide (200 mg)      Diaper Rash
Dimethicone 1.8%         Skin Protectant

Purpose:

OTC - PURPOSE SECTION

Helps treat and prevent diaper rash.
Dries the oozing and weeping of
poison ivy
poison oak
poison sumac

Warnings:

WARNINGS SECTION

For external use only

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

For diaper rash

change wet and soiled diapers promptly
cleanse the diaper area and allow to dry
Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

For poison ivy, oak and sumac

apply ointment liberally as often as needed

Other information

SPL UNCLASSIFIED SECTION

Do not use if seal is punctured or not visible
store at room temperature 15°-30° C (59°-86° F)
avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil

Stop use if

OTC - STOP USE SECTION

conditions worsen
symptoms last more than 7 days or clear up and occur in a few days, consult a physician
over large areas of the body
if you are allergic to these ingredients

Indications and Usage

INDICATIONS & USAGE SECTION

Indications are for diaper rash and general skin protectant.

Do not use

OTC - DO NOT USE SECTION

deep or puncture wounds
animal bites
serious burns

Keep out of reach of children

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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GalShield with Dimethicone

GalShield D.jpg

Galshield

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043605	dimethicone 1.8 % / zinc oxide 20 % Topical Cream	PSN	1
1043605	dimethicone 18 MG/ML / zinc oxide 200 MG/ML Topical Cream	SCD	1
1043605	dimethicone 1.8 % / zinc oxide 20 % Topical Cream	SY	1
1043605	dimethicone 18 MG/ML / ZNO 200 MG/ML Topical Cream	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50382-012-01	2019-11-27	C162847	48780-1	9855d018-d706-cd31-e053-dbdaa90ab51a	Galshield Zinc Oxide / Dimethicone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50382-012-01	Zinc Oxide and Dimethiconewith Dimethicone	113.4 g in 1 TUBE	CREAM	113.4		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50382-012	ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1	Legacy NDC, 1 package rows	20130809_987f3500-e7b4-45bc-bb29-8b5b59b9bb4b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	1
CETETH-10	INACTIVE INGREDIENT	LF9X1PN3XJ	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	1
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	1
STEARETH-20	INACTIVE INGREDIENT	L0Q8IK9E08	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

Zinc Oxide and Dimethicone with Dimethicone
Zinc Oxide and Dimethicone
ZINC OXIDE
DIMETHICONE
ALOE VERA LEAF
CETYL ALCOHOL
CHOLECALCIFEROL
LANOLIN
METHYLPARABEN
MINERAL OIL
PETROLATUM
WATER
CETETH-10
PARAFFIN
PROPYLPARABEN SODIUM
GLYCERIN
PHENOXYETHANOL
STEARETH-20
POLYETHYLENE GLYCOL 6000
POLYSORBATE 60
CETOSTEARYL ALCOHOL
VITAMIN A
ALPHA-TOCOPHEROL
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50382-012	50382-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
DIMETHICONE	92RU3N3Y1O	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
LANOLIN	7EV65EAW6H	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
WATER	059QF0KO0R	IACT
CETETH-10	LF9X1PN3XJ	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PROPYLPARABEN SODIUM	625NNB0G9N	IACT
GLYCERIN	PDC6A3C0OX	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
STEARETH-20	L0Q8IK9E08	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
VITAMIN A	81G40H8B0T	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
TROLAMINE	9O3K93S3TK	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 · 325 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CETETH-10	CETETH-10	LF9X1PN3XJ	LOTION / TOPICAL	2.5 %w/w		Exact identifier — unii candidate
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	POWDER / TOPICAL	0.02 mg/mg		Exact identifier — unii candidate 22 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN SODIUM	PROPYLPARABEN SODIUM	625NNB0G9N	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOAP / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, COATED / ORAL	106 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, EXTENDED RELEASE / ORAL		250 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	CAPSULE, EXTENDED RELEASE / ORAL		302 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	SUPPOSITORY / RECTAL	128 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	EMULSION / ORAL	20 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 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
c824ad2f-391a-464f-a444-7b7d43d75038			987f3500-e7b4-45bc-bb29-8b5b59b9bb4b	2013-08-09	Warnings	Exact identifier spl id: c824ad2f-391a-464f-a444-7b7d43d75038 spl set id: 987f3500-e7b4-45bc-bb29-8b5b59b9bb4b

Reported adverse events (FAERS/openFDA)#

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