Label: BELUCIE LUXURY TIMELESS GOLDEN AGE NIGHT- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50410-070-01 - Packager: KIMJEONGMOON ALOE CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 30, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
Aloe Barbadensis Leaf Extract, Glycerin, Butylene Glycol, Dipropylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Hydrogenated Poly(C6-14 Olefin), Octyldodecyl Myristate, Caprylic/Capric Triglyceride, Niacinamide, Stearyl Alcohol, Glyceryl Stearate SE, Glyceryl Stearate, PEG-100 Stearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-3 Methylglucose Distearate, Water, Diisostearyl Malate, Sorbitan Stearate, C14-22 Alcohols, C12-20 Alkyl Glucoside, Mica (CI 77019), Titanium Dioxide (CI 77891), Ammonium Acryloyldimethyltaurate/VP Copolymer, Methylparaben, Phenoxyethanol, Fragrance(Parfum), Dipotassium Glycyrrhizate, Propylparaben, Triethanolamine, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine, Disodium EDTA, Lecithin, Alcohol, Argania Spinosa Kernel Extract, Butylparaben, Ethylparaben, Isobutylparaben, Polysorbate 80, Saccharomyces/Xylinum/Black Tea Ferment, Sodium Polyacrylate, Propylene Glycol, PVM/MA Copolymer, Iron Oxides (CI 77491), Gold, Caviar Extract, Sigesbeckia Orientalis Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Yellow 6, Rabdosia Rubescens Extract, Sodium Cocoyl Glutamate, Carbomer, Sodium Ascorbyl Phosphate, Hydroxyethylcellulose, Potassium Sorbate, Platinum Powder - PURPOSE
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WARNINGS
Warnings
1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dematologists.
2. In case of having problems such as red spots, swelling, itching and irritation during usage
3. In case the above symptoms emerge due to direct exposure to sunlight
4. Please do not apply the skin to areas affected by eczema and dermatitis - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BELUCIE LUXURY TIMELESS GOLDEN AGE NIGHT
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50410-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.5 g in 50 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Glycerin (UNII: PDC6A3C0OX) Butylene Glycol (UNII: 3XUS85K0RA) Dipropylene Glycol (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50410-070-01 50 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2012 Labeler - KIMJEONGMOON ALOE CO., LTD. (689253722) Registrant - KIMJEONGMOON ALOE CO., LTD. (689253722) Establishment Name Address ID/FEI Business Operations KIMJEONGMOON ALOE CO., LTD. 689253722 repack(50410-070) Establishment Name Address ID/FEI Business Operations COSMAX INC. 689019313 manufacture(50410-070)
