Eight Hour Cream Skin Protectant

Manufacturer: Elizabeth Arden, Inc
Effective date: 2011-01-14
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:29:43

Label at a glance#

ProductEight Hour Cream Skin Protectant

Active ingredientPETROLATUM

Label structure10 sections

Indications and uses

To Use: Apply liberally as often as necessary.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

(On Box) Uses: Treats symptoms of: chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions, cracked lips.

(On Tube) Soothes minor skin irritations. Also for symptoms of chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions or cracked lips.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

To Use: Apply liberally as often as necessary.

WARNINGS

WARNINGS SECTION

(On Box) 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 persist more than 7 days.

(On Tube) Warning: For external use only. Avoid contact with eyes. Discontinue use if symptoms persist more than 7 days and consult a physician. Not to be applied over puncture wounds, infections, or lacerations.

OTC - ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Petrolatum 56.8%.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Lanolin, Mineral Oil, Tocopherol, BHT, Salicylic Acid, Rincinus Communis (Castor) Seed Oil, Vegetable Oil, Zea Mays (Corn) Oil, Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Propylparaben, 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eight Hour Cream Skin Protectant Box

Eight Hour Cream Skin Protectant Tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-0105-1	2020-01-31	C162847	48780-1	9d75b9d0-5d64-f424-e053-dadaa90a57ce	BC0105
67938-0105-3	2020-01-31	C162847	48780-1	9d75b9d0-5d64-f424-e053-dadaa90a57ce	BC0105
67938-0105-5	2020-01-31	C162847	48780-1	9d75b9d0-5d64-f424-e053-dadaa90a57ce	BC0105

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67938-0105-1	Eight Hour Cream Skin Protectant	1 in 1 BOX	LOTION	1	5
67938-0105-2	Eight Hour Cream Skin Protectant	50 g in 1 TUBE	LOTION	50	5
67938-0105-3	Eight Hour Cream Skin Protectant	1 in 1 BOX	LOTION	1	5
67938-0105-4	Eight Hour Cream Skin Protectant	15 g in 1 TUBE	LOTION	15	5
67938-0105-5	Eight Hour Cream Skin Protectant	1 in 1 BOX	LOTION	1	5
67938-0105-6	Eight Hour Cream Skin Protectant	30 g in 1 TUBE	LOTION	30	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-0105	EIGHT HOUR CREAM SKIN PROTECTANT (PETROLATUM) LOTION [ELIZABETH ARDEN, INC]	5	Legacy NDC, 6 package rows	20111006_a2647f00-eb2c-4be8-9c46-d100b0447e92.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	5
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	5
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	5
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	5
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	5
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	5
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	5
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	5
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	5

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Eight Hour Cream Skin Protectant
Petrolatum
LANOLIN
MINERAL OIL
SALICYLIC ACID
PROPYLPARABEN
CASTOR OIL
CORN OIL
ALPHA-TOCOPHEROL
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67938-0105	67938-0105-2, 67938-0105-1, 67938-0105-4, 67938-0105-3, 67938-0105-6, 67938-0105-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	ACTIB
LANOLIN	7EV65EAW6H	IACT
MINERAL OIL	T5L8T28FGP	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
CASTOR OIL	D5340Y2I9G	IACT
CORN OIL	8470G57WFM	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	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 3 · 176 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	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	TABLET / ORAL	20 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 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	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	SUSPENSION / ORAL	2.5 ml/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	TABLET, EXTENDED RELEASE / ORAL	10 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	SUSPENSION, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 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
ada6ff1f-ad9e-4dc5-86a3-09a539a0da20			a2647f00-eb2c-4be8-9c46-d100b0447e92	2011-01-14	Warnings	Exact identifier spl id: ada6ff1f-ad9e-4dc5-86a3-09a539a0da20 spl set id: a2647f00-eb2c-4be8-9c46-d100b0447e92

Reported adverse events (FAERS/openFDA)#

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