Label: CELLADIX SEBUM REBALANCING RX 131 AMPOULE- niacinamide, adenosine solution/ drops
- NDC Code(s): 83490-601-01
- Packager: 2359 US INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 9, 2023
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Inactive Ingredients
Water, Dipropylene Glycol, Butylene Glycol, Glycereth-26, Niacinamide, Glycerin, Betain, Phytosterols, Ceramide NP, Squalane, Lauric Acid, Arachidic Acid, Behenic Acid, Beta-Glucan, Paulownia Tomentosa Leaf Extract, Cinnamomum Cassia Bark Extract, Cinnamomum Japonicum Leaf Extract, Cinnamomum Camphora (Camphor) Leaf Extract, Laurus Nobilis Leaf Extract, Coriandrum Sativum (Coriander) Extract, Eucalyptus Globulus Leaf Extract, Scutellaria Baicalensis Root Extract, Machilus Thunbergii Branch Extract, 1,2-Hexanediol, Polyglyceryl-10 Laurate, Polyglyceryl-10 Myristate, Hydroxyacetophenone, Panthenol, Adenosine, Disodium EDTA, Sodium Hyaluronate, Xanthan Gum, Sodium Polyacrylate, Ethylhexylglycerin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Amyris Balsamifera Bark Oi, Ocimum Basilicum (Basil) Oil, Limonene, Linalool
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INGREDIENTS AND APPEARANCE
CELLADIX SEBUM REBALANCING RX 131 AMPOULE
niacinamide, adenosine solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83490-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 mL ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 g in 100 mL Inactive Ingredients Ingredient Name Strength LAURIC ACID (UNII: 1160N9NU9U) BEHENIC ACID (UNII: H390488X0A) CINNAMOMUM CAMPHORA LEAF (UNII: A0TKE4ZO0S) BAY LEAF (UNII: WS0Y3M85RF) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) BETAINE (UNII: 3SCV180C9W) ARACHIDIC ACID (UNII: PQB8MJD4RB) PAULOWNIA TOMENTOSA LEAF (UNII: D175ZR7P0C) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) POLYGLYCERYL-10 MYRISTATE (UNII: Y9WL8QN3ZB) PANTHENOL (UNII: WV9CM0O67Z) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) XANTHAN GUM (UNII: TTV12P4NEE) AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E) LAVANDIN OIL (UNII: 9RES347CKG) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CERAMIDE NP (UNII: 4370DF050B) SQUALANE (UNII: GW89575KF9) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) BASIL OIL (UNII: Z129UMU8LE) LINALOOL, (+/-)- (UNII: D81QY6I88E) ORANGE OIL (UNII: AKN3KSD11B) WATER (UNII: 059QF0KO0R) LAVENDER OIL (UNII: ZBP1YXW0H8) GLYCERETH-26 (UNII: NNE56F2N14) CHINESE CINNAMON (UNII: WS4CQ062KM) MACHILUS THUNBERGII BRANCH (UNII: 301F5K1I0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BERGAMOT OIL (UNII: 39W1PKE3JI) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83490-601-01 20 mL in 1 AMPULE; Type 0: Not a Combination Product 05/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/24/2023 Labeler - 2359 US INC (118974080) Registrant - 2359 US INC (118974080) Establishment Name Address ID/FEI Business Operations isamogu Inc. 695695834 manufacture(83490-601)
