EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE

Dosage form: cream
Ingredients: PETROLATUM 28.4g in 50g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-1149

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.

BC1149

DESCRIPTION

This fragrance free version of the legendary skincare classic works wonders to moisturize and protect anytime, anyway you choose.  Shape brows, revitalize shine, soothe dry hands and smooth cuticles and nails.

INDICATIONS AND USAGE

To use: Apply liberally as often as necessary.

WARNINGS

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 persists more than 7 days.

OTC - ACTIVE INGREDIENT

Active Ingredient: Petrolatum 56.8%

INACTIVE INGREDIENT

LANOLIN, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINÉRALE, ACACIA DECURRENS EXTRACT, DIPTERYX ODORATA BEAN EXTRACT, VANILLIN, TOCOPHEROL, TOCOPHERYL ACETATE, BHT, SALICYLIC ACID, RICINUS COMMUNIS (CASTOR) SEED OIL, VEGETABLE OIL/OLUS/HUILE VÉGÉTALE, ZEA MAYS (CORN) OIL, BENZYL ALCOHOL, 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. Do not apply over puncture wounds, infections or lacerations.

EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1149
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 
VANILLIN 
SALICYLIC ACID 
Packaging
#Item CodePackage Description
1NDC:67938-1149-11 TUBE (1 TUBE) in 1 BOX
1NDC:67938-1149-250 g in 1 TUBE
2NDC:67938-1149-32 g in 1 PACKET
3NDC:67938-1149-41 TUBE (1 TUBE) in 1 BOX
3NDC:67938-1149-528 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/07/2011
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 10/2011
 
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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