Label: CELESTY ACNE SERIES DEEP CLEANSING GEL- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 7, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts:

  • Active Ingredients

    Salicylic Acid : 2%

  • Purpose

    Acne treatment

  • Use

    For the treatment of acne

  • Warnings

    For external use only. Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Additional Information

    You may experience mild redness, a warm, tingling sensation or flaking (skin exfoliation). These are normal, temporary indications that the formula is working. If effects persist or cause discomfort, limit use to once every 2 to 3 days until your skin adjusts, then revert to daily use.

    Sunburn Alert This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen and limit sun exposure while using this product. Store at room temperature.

  • Directions

    Apply by massaging into your skin with lukewarm water morning and/or evening. Avoid contact with the eye area. Rinse well and dry. 

    For peeling treatment: Apply a thin layer without wetting or massaging. Wait for 1 minute and rinse. Usage with high factor sunscreen is recommended. 

  • Inactive Ingredients

    Water\Aqua\Eau, Glycolic Acid, Sodium Laureth Sulfate, Cocamidopropyl Hydroxysultaine, Glycerin, Ammonium Laureth Sulfate, PEG-7 Glyceryl Cocoate, Lactic Acid, Di-PPG-2 Myreth-10 Adipate, Ammonium Hydroxide, Lavandula Angustifolia (Lavender) Oil, Hydroxypropyl Methylcellulose, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Soapwort (Saponaria Officinalis) Root Extract

  • SPL UNCLASSIFIED SECTION

    clarify with ACNE series

    SALICYLIC ACID

    GLYCOLIC ACID

    HERBAL EXTRACTS

    BEAUTY CARE

    (FOR ACNE - PRONE SKIN)

    Gentle gel cleanser formulated for the specific needs of acne prone skin. Contains salicylic acid, lactic acid and rich herbal extracts for antibacterial properties.

    Brace Beauty, Embrace Purity.

    www.celesty.com

    Made in TURKEY

    MABA KOZMETIK A.S.

    ESENTEPE MAH. YUZBASI KAYA ALDOGAN SOK.

    ONUR IS MERKEZI NO:12 D:8 ISTANBUL

    Distributed by CELESTY LLC

    3970 NW 167TH ST. MIAMI GARDENS,

    FL 33054 - USA

    info@celesty.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CELESTY  ACNE SERIES DEEP CLEANSING GEL
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)  
    AMMONIA (UNII: 5138Q19F1X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ROSEMARY (UNII: IJ67X351P9)  
    SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-102-011 in 1 BOX12/07/2020
    1200 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/07/2020
    Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418)
    Establishment
    NameAddressID/FEIBusiness Operations
    MABA KOZMETIK LIMITED SIRKETI503001418manufacture(81120-102)