EIGHT HOUR CREAM SKIN PROTECTANT - petrolatum lotion
Elizabeth Arden, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

Eight Hour Cream Skin Protectant Box

Eight Hour Cream Skin Protectant Tube

EIGHT HOUR CREAM SKIN PROTECTANT
petrolatum lotion

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (PETROLATUM)	PETROLATUM	28.4 g in 50 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN
MINERAL OIL
SALICYLIC ACID
PROPYLPARABEN
CASTOR OIL
CORN OIL
ALPHA-TOCOPHEROL
BUTYLATED HYDROXYTOLUENE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67938-0105-1	1 TUBE (1 TUBE) in 1 BOX	contains a TUBE (67938-0105-2)
1	NDC:67938-0105-2	50 g in 1 TUBE	This package is contained within the BOX (67938-0105-1)
2	NDC:67938-0105-3	1 TUBE (1 TUBE) in 1 BOX	contains a TUBE (67938-0105-4)
2	NDC:67938-0105-4	15 g in 1 TUBE	This package is contained within the BOX (67938-0105-3)

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)

Revised: 01/2011 Elizabeth Arden, Inc