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.

----------

BC0105

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM28.4 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67938-0105-11 in 1 BOX
1NDC:67938-0105-250 g in 1 TUBE
2NDC:67938-0105-31 in 1 BOX
2NDC:67938-0105-415 g in 1 TUBE
3NDC:67938-0105-51 in 1 BOX
3NDC:67938-0105-630 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/03/2009
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 1/2011
Document Id: ada6ff1f-ad9e-4dc5-86a3-09a539a0da20
Set id: a2647f00-eb2c-4be8-9c46-d100b0447e92
Version: 5
Effective Time: 20110114
 
Elizabeth Arden, Inc