83490-604 Celladix Acne Control Gel Cleanser

Celladix Acne Control Gel Cleanser by

Drug Labeling and Warnings

Celladix Acne Control Gel Cleanser 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 ACNE CONTROL GEL CLEANSER- salicylic acid gel 
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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83490-604 Celladix Acne Control Gel Cleanser

Active Ingredients

Salicylic Acid 0.5%

Purposes

Salicylic Acid 0.5% ------- Acne treatment

Uses

For the treatment of acne and helps to control excessive oil secretion.

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

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Directions

Use an appropriate amount of the cleanser and gently rinse off with water.

Inactive Ingredients

Water, Disodium Laureth Sulfosuccinate, Lauryl Glucoside, Glycerin, Cocamide MEA, Butylene Glycol, Salicylic Acid, Lauryl Hydroxysultaine, Chlorphenesin, PEG-60 Hydrogenated Castor Oil, Polyquaternium-10, Potassium Cocoyl Glycinate, Sodium Benzoate, Citric Acid, Sodium Chloride, Ethylhexylglycerin, Dipotassium Glycyrrhizate, Panthenol, Disodium EDTA, 1,2- Hexanediol, Caramel, Cynanchum Atratum Extract, Phellodendron Amurense Bark Extract, Paeonia Suffruticosa Root Extract, Camellia Sinensis Leaf Extract, Mentha Arvensis Extract, Psidium Guajava Leaf Extract, Rosa Hybrid Flower Extract, Scutellaria Baicalensis Root Extract, Saccharide Isomerate, Sodium Citrate, Fragrance, Geraniol, Limonene

Label

CELLADIX ACNE CONTROL GEL CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PSIDIUM GUAJAVA LEAF (UNII: PM0F263X0Y)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PANTHENOL (UNII: WV9CM0O67Z)
MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CARAMEL (UNII: T9D99G2B1R)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CHLORPHENESIN (UNII: I670DAL4SZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
GERANIOL (UNII: L837108USY)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-604-01	110 mL in 1 BOTTLE, PUMP; 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(83490-604)

Revised: 7/2024

Document Id: 1e63c9e6-87f0-6c70-e063-6394a90ab1cb

34390-5

Set id: f6741dd0-0c4d-a06b-e053-2995a90ace85

Version: 2

Effective Time: 20240729