Label: FEDORA ORIENTAL SPA AMPOULE- glycerin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 62620-1001-1, 62620-1001-2 - Packager: Fedora International 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 March 6, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Water, Glycerin, Beta-Glucan, Butylene Glycol, Glyceryl Acrylate, Acrylic Acid Copolymer, Propylene Glycol, Dimethicone, Niacinamide, Trehalose, Dipropylene Glycol, Glycosyl trehalose, Hydrolyzed Collagen, Silkworm cocoon extract, butylene glycol/Polygonum Fagopyrum Seed Extract, Aristotelia Chilensis Fruit Extract, Phyllanthus Emblica Fruit Extract, Hippophae Rhamnoides Extract, Pueraria Thunbergiana Root Extract, Angelica Dahurica Root Extract, Saposhnikovia Divaricata Root Extract, Atractyloides Chinensis Rhizome Extract, Panax Ginseng Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Lactiflora Root Extract, Astragalus Membranaceus Root Extract, Cimicifuga Dahurica Root Extract, Cryptomeria Japonica Leaf Extract, Aloe Barbadensis Leaf Extract, Ligustrum Japonicum Fruit Extract, Centella asiatica extract, Panax Ginseng Root Extract, Hippophae Rhamnoides Fruit Extract, Cornus Officinalis Fruit Extract, Gynostemma Pentaphyllum Extract, Eclipta Prostrata Extract, Caulerpa Lentillifera Extract, Codium Fragile Extract, Hamamelis Virginiana (Witch Hazel) Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Tremella Fuciformis (Mushroom) Extract, Donkey milk, Camel Milk, Xylitylglucoside, anhydroxylitol, xylitol, Sodium Hyaluronate, PEG-60 Hydrogenated castor oil, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Cholesterol, Octyldodecanol, Ubiquinone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tremella Fuciformis Polysaccharide, Hydroxypropyl Cyclodextrin, Thioctic acid, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, 1,2-Hexanediol, Caramel, Xanthan Gum, Adenosine, Sodium Polyacrylate, Disodium EDTA, Carbomer, Tromethamine, Lecithin, Fragrance
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEDORA ORIENTAL SPA AMPOULE
glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62620-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.0798 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BETAINE (UNII: 3SCV180C9W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62620-1001-2 28 in 1 PACKAGE 1 NDC:62620-1001-1 2 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/06/2014 Labeler - Fedora International Co., Ltd. (689049099) Registrant - Fedora International Co., Ltd. (689049099) Establishment Name Address ID/FEI Business Operations Fedora International Co., Ltd. 689049099 manufacture(62620-1001)
