83490-605 Celladix C.E.F ADVANCED BRIGHTENING AMPOULE

Celladix C.E.F ADVANCED BRIGHTENING AMPOULE by

Drug Labeling and Warnings

Celladix C.E.F ADVANCED BRIGHTENING 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 C.E.F ADVANCED BRIGHTENING AMPOULE- ascorbic acid liquid 
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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83490-605 Celladix C.E.F ADVANCED BRIGHTENING AMPOULE

Active Ingredients

Ascorbic Acid

Purposes

Skin Brightening

Uses

Helps to brighten facial skin tone.

Warnings

Do not use it on open wounds and sensitive skin.

Warnings

Keep out of reach of children

Warnings

When using this product keep out of eyes. Rinse with water to remove

Directions

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

Inactive Ingredients

Warnings

For external use only

Warnings

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

Label

label

CELLADIX C.E.F ADVANCED BRIGHTENING AMPOULE 
ascorbic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-605
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ASTAXANTHIN (UNII: 8XPW32PR7I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECETH-16 (UNII: RJV574G0DE)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)
TRIBUTYL CITRATE (UNII: 827D5B1B6S)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CYSTOSEIRA TAMARISCIFOLIA (UNII: HRU0KH4VFH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACACIA (UNII: 5C5403N26O)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
OLIVE OIL (UNII: 6UYK2W1W1E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
PANTHENOL (UNII: WV9CM0O67Z)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ARBUTIN (UNII: C5INA23HXF)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
POVIDONE (UNII: FZ989GH94E)
GLUTATHIONE (UNII: GAN16C9B8O)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
BETAINE (UNII: 3SCV180C9W)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SUCROSE (UNII: C151H8M554)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
FURTERENE (UNII: TY1X1WG26A)
GLYCERIN (UNII: PDC6A3C0OX)
ORANGE PEEL (UNII: TI9T76XD44)
UBIDECARENONE (UNII: EJ27X76M46)
BUTETH-3 (UNII: OC116GRO69)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
MORUS ALBA BARK (UNII: 7O71A48NDP)
SODIUM ASCORBATE (UNII: S033EH8359)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BETA CAROTENE (UNII: 01YAE03M7J)
ADENOSINE (UNII: K72T3FS567)
.BETA.-GLUCOGALLIN (UNII: 4X7JGS9BFY)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
VINCETOXICUM ATRATUM WHOLE (UNII: U3176B0S5J)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-605-01	15 mL in 1 AMPULE; Type 0: Not a Combination Product	07/24/2023	07/29/2024

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

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
Isamogu Inc.		695695834	manufacture(83490-605)

Revised: 7/2024

Document Id: 1e63a78b-0546-9c39-e063-6394a90ac5e0

34390-5

Set id: 0171c4a5-da53-1f0b-e063-6394a90ad3b2

Version: 2

Effective Time: 20240729