EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE

Manufacturer: Elizabeth Arden, Inc
Effective date: 2011-10-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:29:44

Label at a glance#

ProductEIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE

Active ingredientPETROLATUM

Label structure10 sections

Indications and uses

To use: Apply liberally as often as necessary.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

This fragrance free version of the legendary skincare classic works wonders to moisturize and protect anytime, anyway you choose. Shape brows, revitalize shine, soothe dry hands and smooth cuticles and nails.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

To use: Apply liberally as often as necessary.

WARNINGS

WARNINGS SECTION

Warnings: For external use only. When using this product avoid contact with eyes. Do not apply over puncture wounds, infections or lacerations. Stop using and ask a doctor if symptoms persists more than 7 days.

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Petrolatum 56.8%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

LANOLIN, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINÉRALE, ACACIA DECURRENS EXTRACT, DIPTERYX ODORATA BEAN EXTRACT, VANILLIN, TOCOPHEROL, TOCOPHERYL ACETATE, BHT, SALICYLIC ACID, RICINUS COMMUNIS (CASTOR) SEED OIL, VEGETABLE OIL/OLUS/HUILE VÉGÉTALE, ZEA MAYS (CORN) OIL, BENZYL ALCOHOL, IRON OXIDES.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply liberally.

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE

OTC - PURPOSE SECTION

Skin protectant.

OTC - WHEN USING

OTC - WHEN USING SECTION

Avoid contact with eyes. Do not apply over puncture wounds, infections or lacerations.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1189921	petrolatum 56.8 % Topical Cream	PSN	1
1189921	petrolatum 568 MG/ML Topical Cream	SCD	1
1189921	petrolatum 56.8 % Topical Cream	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-1149-1	2020-01-31	C162847	48780-1	9d75b9d0-3070-f424-e053-dadaa90a57ce	BC1149
67938-1149-3	2020-01-31	C162847	48780-1	9d75b9d0-3070-f424-e053-dadaa90a57ce	BC1149
67938-1149-4	2020-01-31	C162847	48780-1	9d75b9d0-3070-f424-e053-dadaa90a57ce	BC1149

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67938-1149-1	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	1 in 1 BOX	CREAM	1	1
67938-1149-2	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	50 g in 1 TUBE	CREAM	50	1
67938-1149-3	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	2 g in 1 PACKET	CREAM	2	1
67938-1149-4	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	1 in 1 BOX	CREAM	1	1
67938-1149-5	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE	28 g in 1 TUBE	CREAM	28	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-1149	EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE (PETROLATUM) CREAM [ELIZABETH ARDEN, INC]	1	Legacy NDC, 5 package rows	20111011_afa8c6d1-2a26-4506-8f3e-35a2a22dcfcc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
VANILLIN	INACTIVE INGREDIENT	CHI530446X	1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE
PETROLATUM
LANOLIN
MINERAL OIL
VANILLIN
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67938-1149	67938-1149-2, 67938-1149-1, 67938-1149-3, 67938-1149-5, 67938-1149-4

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
PETROLATUM	4T6H12BN9U	ACTIB
LANOLIN	7EV65EAW6H	IACT
MINERAL OIL	T5L8T28FGP	IACT
VANILLIN	CHI530446X	IACT
SALICYLIC ACID	O414PZ4LPZ	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 · 54 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	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET, EXTENDED RELEASE / ORAL	3.4 mg		Exact identifier — unii candidate 15 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	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	ELIXIR / ORAL	NA		Exact identifier — unii candidate 15 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	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 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	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET / ORAL		12 mg	Exact identifier — unii candidate 15 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	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	POWDER, FOR SUSPENSION / ORAL	2 mg/1ml		Exact identifier — unii candidate 15 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	SYRUP / ORAL	NA		Exact identifier — unii candidate 15 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	OINTMENT / TOPICAL		9938 mg	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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET, FILM COATED / ORAL		5 mg	Exact identifier — unii candidate 15 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	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET, CHEWABLE / ORAL	2.5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET, ORALLY DISINTEGRATING / ORAL	0.26 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	SOLUTION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	SUSPENSION / ORAL		6 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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	LIQUID / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
VANILLIN	VANILLIN	CHI530446X	TABLET, COATED / ORAL	65.5 mg		Exact identifier — unii candidate 15 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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		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
9f78a938-c8af-460d-ae67-e75a5b1f6ad6			afa8c6d1-2a26-4506-8f3e-35a2a22dcfcc	2011-10-04	Warnings	Exact identifier spl id: 9f78a938-c8af-460d-ae67-e75a5b1f6ad6 spl set id: afa8c6d1-2a26-4506-8f3e-35a2a22dcfcc

Reported adverse events (FAERS/openFDA)#

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