ZINC OXIDE

Manufacturer: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Effective date: 2021-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 22:22:41

Label at a glance#

ProductZINC OXIDE

Active ingredientZINC OXIDE

Label structure12 sections

Contacts and useful links#

PhoneLabel contact1-800-645-9833

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (200 mg)

Purpose:

OTC - PURPOSE SECTION

Skin protectant

INDICATIONS & USAGE SECTION

Uses:

helps treat and prevent diaper rash
dries the oozing and weeping of:
poison ivy
poison oak
poison sumac

WARNINGS SECTION

Warnings:

If condition worsens or dose not improve within seven days, consult physician.

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.

FOR EXTERNAL USE ONLY

AVOID CONTACT WITH EYES

DOSAGE & ADMINISTRATION SECTION

Directions:

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

SPL UNCLASSIFIED SECTION

Other information:

do not use if seal is punctured or is not visible
use cap to puncture seal
store at temperature
do not exceed 30° C (86° F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

mineral oil, white petrolatum, white wax

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0062-31

Fougera^®

Zinc Oxide Ointment USP

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0062-31

Fougera^®

Zinc Oxide Ointment USP

Skin Protectant

To reliably help soothe and protect chafed skin.

INDICATION: Helps and prevent diaper rash. Protects chafed skin due to diaper rash and helps protect from wetness. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera^®

NDC 0168-0062-16

Zinc Oxide
Ointment USP

NET WT 453.6 g (1 lb)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0168-0062-02	2021-12-15	C162847	48780-1	9d75b9d0-6bc5-f424-e053-dadaa90a57ce	ZINC OXIDE
0168-0062-16	2021-12-15	C162847	48780-1	9d75b9d0-6bc5-f424-e053-dadaa90a57ce	ZINC OXIDE
0168-0062-31	2021-12-15	C162847	48780-1	9d75b9d0-6bc5-f424-e053-dadaa90a57ce	ZINC OXIDE
0168-0062-02	2020-01-31	C162847	48780-1	9d75b9d0-6bc5-f424-e053-dadaa90a57ce	ZINC OXIDE
0168-0062-16	2020-01-31	C162847	48780-1	9d75b9d0-6bc5-f424-e053-dadaa90a57ce	ZINC OXIDE
0168-0062-31	2020-01-31	C162847	48780-1	9d75b9d0-6bc5-f424-e053-dadaa90a57ce	ZINC OXIDE

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0062-02	GM - Gram	0168-0062	49fb94b5-19ca-4712-99fe-ccf468be4b24	1	2013-02-13
0168-0062-16	GM - Gram	0168-0062	c2e6a7cb-54a3-4270-aec9-126ef359b210	1	2013-02-13
0168-0062-31	GM - Gram	0168-0062	dbc01c38-ffd2-479d-9a25-c7a0a8096813	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

ZINC OXIDE
MINERAL OIL
PETROLATUM
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0168-0062	0168-0062-31, 0168-0062-02, 0168-0062-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
WHITE WAX	7G1J5DA97F	IACT

Source Document#

Source XML · Source PDF

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 2 · 63 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	SUPPOSITORY / RECTAL	265 mg		Exact identifier — unii candidate 15 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	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / TOPICAL		500 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET / ORAL	5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, EXTENDED RELEASE / ORAL	14 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 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
0de9ae0e-3a33-4999-b200-e6533796fb40			ee65a059-7df4-4d5e-a70e-14861764597e	2021-12-15	Warnings	Exact identifier spl id: 0de9ae0e-3a33-4999-b200-e6533796fb40 spl set id: ee65a059-7df4-4d5e-a70e-14861764597e

Reported adverse events (FAERS/openFDA)#

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