Zinc Oxide Ointment

Manufacturer: Galentic Pharma (India) Priva Te Limited
Effective date: 2013-07-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:36:20

Label at a glance#

ProductZinc Oxide

Active ingredientZINC OXIDE

Label structure10 sections

Indications and uses

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

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, poison oak, poison sumac: apply liberally as often as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Section Text

Active Ingredient Purpose

Zinc Oxide (200mg in each gram) Skin Protectant

Uses:

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

When using this product:

OTC - WHEN USING SECTION

Do not get in eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

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

Do not use on:

INDICATIONS & USAGE 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.

Directions:

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, poison oak, poison sumac:

apply liberally as often as needed

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Galzinc.jpg

Galentic zinc oxide

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50382-051-01	2019-11-27	C162847	48780-1	9855d018-d49c-cd31-e053-dbdaa90ab51a	Zinc Oxide Ointment
50382-051-02	2019-11-27	C162847	48780-1	9855d018-d49c-cd31-e053-dbdaa90ab51a	Zinc Oxide Ointment
50382-051-03	2019-11-27	C162847	48780-1	9855d018-d49c-cd31-e053-dbdaa90ab51a	Zinc Oxide Ointment

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50382-051	ZINC OXIDE OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]	4	Legacy NDC	20130726_1deec882-5c29-44f8-8a74-4ec5bed2eadc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	4
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	4
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	4
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	4

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Zinc Oxide
CETOSTEARYL ALCOHOL
CETETH-20
LIGHT MINERAL OIL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50382-051	50382-051-03, 50382-051-01, 50382-051-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-20	I835H2IHHX	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
PETROLATUM	4T6H12BN9U	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 1 · 50 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	FILM, EXTENDED RELEASE / TRANSDERMAL	162 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	SYSTEM / TRANSDERMAL		170 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	LOTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	OIL / TOPICAL		2509 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, FILM COATED / ORAL	2.49 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	CREAM / TOPICAL		456 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	CREAM / TOPICAL		429 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	PASTE / DENTAL		687 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	CREAM, AUGMENTED / TOPICAL	25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, COATED / ORAL	4.8 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	SUPPOSITORY / VAGINAL	1464.9 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	AEROSOL, FOAM / TOPICAL		240 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	PASTILLE / ORAL	3.6 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	OINTMENT / TOPICAL		1335 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	OIL / AURICULAR (OTIC)		419 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	EMULSION / TOPICAL		68100 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET / ORAL	7.5 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 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
e1464e9e-9350-4572-ba59-c4c26535fec3			1deec882-5c29-44f8-8a74-4ec5bed2eadc	2013-07-26	Warnings	Exact identifier spl id: e1464e9e-9350-4572-ba59-c4c26535fec3 spl set id: 1deec882-5c29-44f8-8a74-4ec5bed2eadc

Reported adverse events (FAERS/openFDA)#

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