EIGHT HOUR NIGHT- dimethicone emulsion

EIGHT HOUR NIGHT by

Drug Labeling and Warnings

EIGHT HOUR NIGHT by is a Otc medication manufactured, distributed, or labeled by REVLON, Revlon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient Purpose
Dimethicone 2.0%...................................... Skin Protectant

Inactive Ingredients

PETROLATUM, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, LANOLIN, ISONONYL ISONONANOATE, HYDROGENATED POLYISOBUTENE, ISOPROPYL MYRISTATE, ISOPROPYL PALMITATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, POLYBUTENE, TRIISOSTEARIN, OLEYL ERUCATE, POLYPROPYLENE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, SYNTHETIC WAX, CYCLOPENTASILOXANE, RICINUS COMMUNIS (CASTOR) SEED OIL, GLYCERYL BEHENATE/EICOSADIOATE, HYDROGENATED LECITHIN, DIMETHICONOL, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, PARFUM/FRAGRANCE, SALICYLIC ACID, TOCOPHEROL, TOCOPHERYL ACETATE, VEGETABLE OIL/OLUS/HUILE VEGETALE, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, YELLOW 6 LAKE (CI 15985).

Uses and Directions

Uses
- Treats symptoms of chapped or cracked skin.
- Helps prevent and protect from drying effects of wind and cold weather.

Directions

- 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 persist more than 7 days

DOSAGE & ADMINISTRATION

As Needed

INDICATIONS & USAGE

• Treats symptoms of chapped or cracked skin
• Helps prevent and protect from drying effects of wind and cold weather

PURPOSE

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

carton art

INGREDIENTS AND APPEARANCE

EIGHT HOUR NIGHT 
dimethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-675
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SALICYLIC ACID (UNII: O414PZ4LPZ)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
SHEA BUTTER (UNII: K49155WL9Y)
OLEYL ERUCATE (UNII: 753W099NQ6)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
TOCOPHEROL (UNII: R0ZB2556P8)
CORN OIL (UNII: 8470G57WFM)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LANOLIN (UNII: 7EV65EAW6H)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
GERANIOL (UNII: L837108USY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-675-16	45 g in 1 JAR; Type 0: Not a Combination Product	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/20/2020

Labeler - REVLON (788820165)

Registrant - REVLON (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon		809725570	manufacture(10967-675)