Eight Hour Cream Skin Protectant

Dosage form: lotion
Ingredients: PETROLATUM 28.4g in 50g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-0105

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 
petrolatum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM28.4 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN 
MINERAL OIL 
SALICYLIC ACID 
PROPYLPARABEN 
CASTOR OIL 
CORN OIL 
ALPHA-TOCOPHEROL 
BUTYLATED HYDROXYTOLUENE 
Packaging
#Item CodePackage Description
1NDC:67938-0105-11 TUBE (1 TUBE) in 1 BOX
1NDC:67938-0105-250 g in 1 TUBE
2NDC:67938-0105-31 TUBE (1 TUBE) in 1 BOX
2NDC:67938-0105-415 g in 1 TUBE
3NDC:67938-0105-51 TUBE (1 TUBE) 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: 01/2011
 
Elizabeth Arden, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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