EIGHT HOUR CREAM SKIN PROTECTANT- petrolatum lotion

Eight Hour Cream Skin Protectant by

Drug Labeling and Warnings

Eight Hour Cream Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

(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

To Use: Apply liberally as often as necessary.

WARNINGS

(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

Active Ingredient: Petrolatum 56.8%.

INACTIVE INGREDIENT

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

Apply liberally.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Skin protectant.

OTC - WHEN USING

Avoid contact with eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EIGHT HOUR CREAM SKIN PROTECTANT 
petrolatum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	28.4 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CASTOR OIL (UNII: D5340Y2I9G)
CORN OIL (UNII: 8470G57WFM)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0105-1	1 in 1 BOX
1	NDC: 67938-0105-2	50 g in 1 TUBE
2	NDC: 67938-0105-3	1 in 1 BOX
2	NDC: 67938-0105-4	15 g in 1 TUBE
3	NDC: 67938-0105-5	1 in 1 BOX
3	NDC: 67938-0105-6	30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/03/2009

Labeler - Elizabeth Arden, Inc (849222187)