Olivene

Manufacturer: Fischer Pharmaceuticlas Ltd. | Fischer Pharmaceuticals Ltd.
Effective date: 2016-06-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:46:31

Label at a glance#

ProductOlivene Diaper Rash

Active ingredientZinc Oxide

Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness.

Dosage and administration

Change wet and solid diapers promptly Clean the diaper area and allow to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged.

Storage and handling

Store at 20° to 25°C (68° to 77°F)

Contacts and useful links#

PhoneLabel contact1-888-553-6112

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 40%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or lasts more than 7 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Change wet and solid diapers promptly
Clean the diaper area and allow to dry
Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged.

Other Information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Mineral Oil, Petrolatum, Beeswax, Lanolin, Olea Europaea (Olive) Oil Unsaponifiables, Oleyl Erucate, Sorbitan Isostearate, DMDM Hydantoin, Glycyrrhetinic Acid, Propylene Glycol, BHT, Ascorbyl Palmitate, Glyceryl Stearate, Citric Acid.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-553-6112 Mon-Fri

SPL UNCLASSIFIED SECTION

Manufactured by: Fischer Pharmaceuticals LTD.
Bnei Brak 51553, Israel

PRINCIPAL DISPLAY PANEL - 113 g. Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM
STRENGTH

Dr. Fischer^®

NATURE BABY

Olivene^®
Diaper Rash Ointment

Rash Fighting
40% Zinc Oxide & Soothing
Olive Oil, Beeswax & Licorice

Rapid Relief

113 g. 4 oz.

FISCHER PHARMACEUTICALS

Principal Display Panel - 113 g. Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
244638	zinc oxide 40 % Topical Ointment	PSN	2
244638	zinc oxide 0.4 MG/MG Topical Ointment	SCD	2
244638	zinc oxide 40 % Topical Ointment	SY	2
244638	ZNO 0.4 MG/MG Topical Ointment	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59886-413-99	2022-01-28	C162847	48780-1	d6a99b39-cfaf-a426-e053-dadaa90af4c2	Olivene ® Diaper Rash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59886-413-99	Olivene Diaper Rash	1 in 1 CARTON	OINTMENT	1		2
59886-413-99	Olivene Diaper Rash	113 g in 1 TUBE	OINTMENT	113		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59886-413	OLIVENE DIAPER RASH (ZINC OXIDE) OINTMENT [FISCHER PHARMACEUTICLAS LTD.]	2	Legacy NDC, 2 package rows	20160711_4378730e-da7b-401b-bd24-b8e853bd8d2d.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Olivene Diaper Rash
Zinc Oxide
Water
Mineral Oil
Petrolatum
Yellow Wax
Lanolin
Olive Oil
Oleyl Erucate
Sorbitan Isostearate
DMDM Hydantoin
Enoxolone
Propylene Glycol
Butylated Hydroxytoluene
Ascorbyl Palmitate
Glyceryl Monostearate
Citric Acid Monohydrate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59886-413	59886-413-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Zinc Oxide	SOI2LOH54Z	ACTIB
Water	059QF0KO0R	IACT
Mineral Oil	T5L8T28FGP	IACT
Petrolatum	4T6H12BN9U	IACT
Yellow Wax	2ZA36H0S2V	IACT
Lanolin	7EV65EAW6H	IACT
Olive Oil	6UYK2W1W1E	IACT
Oleyl Erucate	753W099NQ6	IACT
Sorbitan Isostearate	01S2G2C1E4	IACT
DMDM Hydantoin	BYR0546TOW	IACT
Enoxolone	P540XA09DR	IACT
Propylene Glycol	6DC9Q167V3	IACT
Butylated Hydroxytoluene	1P9D0Z171K	IACT
Ascorbyl Palmitate	QN83US2B0N	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
Citric Acid Monohydrate	2968PHW8QP	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ea906a2b-f6fd-43ec-abc1-3f3187475c22			4378730e-da7b-401b-bd24-b8e853bd8d2d	2016-06-09	Warnings	Exact identifier spl id: ea906a2b-f6fd-43ec-abc1-3f3187475c22 spl set id: 4378730e-da7b-401b-bd24-b8e853bd8d2d

Reported adverse events (FAERS/openFDA)#

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