EIGHT HOUR SKIN FRAGRANCE FREE- petrolatum cream

EIGHT HOUR SKIN FRAGRANCE FREE by

Drug Labeling and Warnings

EIGHT HOUR SKIN FRAGRANCE FREE by is a Otc medication manufactured, distributed, or labeled by REVLON, Cosmetic Essence, LLC dba Voyant Beauty, Englewood Lab. INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PETROLATUM 56.8%

INACTIVE INGREDIENTS

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

USES

Treats symptoms of:

• chapping
• peeling or flaking due to minor burns
• sunburn
• windburn
• scrapes
• abrasions
• cracked lips

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

DIRECTIONS

Apply liberally as often as necessary

CARTON ART

INGREDIENTS AND APPEARANCE

EIGHT HOUR SKIN FRAGRANCE FREE 
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-673
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	56.8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
ACACIA DECURRENS WHOLE (UNII: 8KZ75S2VSK)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SALICYLIC ACID (UNII: O414PZ4LPZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CORN OIL (UNII: 8470G57WFM)
DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)
VANILLIN (UNII: CHI530446X)
CASTOR OIL (UNII: D5340Y2I9G)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LANOLIN (UNII: 7EV65EAW6H)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-673-17	50 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/15/2013

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC dba Voyant Beauty		032565959	manufacture(10967-673)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab. INC.		080987545	manufacture(10967-673)