Label: EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-2001-1, 67938-2001-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 29, 2013
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- Official Label (Printer Friendly)
- DESCRIPTION
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INDICATIONS AND USAGE
To use: Incorporate as the last step in your nighttime skincare ritual. 1) Dip fingertips into moisturizer, 2) gently warming between your hands. 3) Breathe in the soothing scent of lavender as you 4) lightly massage onto face with small circular motions. Apply generously to other dryness-prone areas such as hands, elbows and legs.
- WARNINGS
- OTC - ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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).
- DOSAGE AND ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-2001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.9 g in 45 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) LANOLIN (UNII: 7EV65EAW6H) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) TRIISOSTEARIN (UNII: 71503RH8KG) OLEYL ERUCATE (UNII: 753W099NQ6) MINERAL OIL (UNII: T5L8T28FGP) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) DIMETHICONOL (40 CST) (UNII: 343C7U75XW) GLYCERYL CITRATE (UNII: 4987GT719I) SALICYLIC ACID (UNII: O414PZ4LPZ) TOCOPHEROL (UNII: R0ZB2556P8) BENZYL SALICYLATE (UNII: WAO5MNK9TU) CITRONELLOL ACETATE, (R)- (UNII: 9X45FJL446) GERANIOL (UNII: L837108USY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-2001-1 1 in 1 BOX 1 NDC:67938-2001-2 45 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part310.545 05/07/2013 Labeler - Elizabeth Arden, Inc (849222187)
