83490-601 Celladix Sebum Rebalancing Rx 131 Ampoule

Celladix Sebum Rebalancing Rx 131 Ampoule by

Drug Labeling and Warnings

Celladix Sebum Rebalancing Rx 131 Ampoule by is a Otc medication manufactured, distributed, or labeled by 2359 US INC, isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CELLADIX SEBUM REBALANCING RX 131 AMPOULE- niacinamide, adenosine solution/ drops 
2359 US INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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83490-601 Celladix Sebum Rebalancing Rx 131 Ampoule

Active Ingredients

Niacinamide 2.0%
Adenosine 0.04%

Purposes

Niacinamide 2.0% ------------ Skin protectant
Adenosine 0.04% ------------ Astringent

Uses

For skin barrier repair, perfect for oily skin

Warnings

For external use only.

Warnings

Do not use it on open wounds and sensitive skin.

Warnings

Keep out of reach of children.

Warnings

Stop use and ask a doctor If there are any abnormal symptoms or side effects such as red spots, swelling, or itching during or immediately after use

Warnings

Directions

After cleansing or toning, take an appropriate amount of the ampoule and gently spread it over the face for absorption

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

Label

CELLADIX SEBUM REBALANCING RX 131 AMPOULE 
niacinamide, adenosine solution/ drops

Product 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	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/24/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
isamogu Inc.		695695834	manufacture(83490-601)

Revised: 7/2024

Document Id: 1e639f84-8e47-6d0b-e063-6394a90a3096

34390-5

Set id: f673e59f-7c53-3e2c-e053-2995a90ac7b5

Version: 2

Effective Time: 20240729