Label: CELLADIX ACNE CONTROL GEL CLEANSER- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated March 9, 2023

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  • 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

  • INGREDIENTS AND APPEARANCE
    CELLADIX ACNE CONTROL GEL CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83490-604-01110 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/24/2023
    Labeler - 2359 US INC (118974080)
    Registrant - 2359 US INC (118974080)
    Establishment
    NameAddressID/FEIBusiness Operations
    isamogu Inc.695695834manufacture(83490-604)