Label: CELESTY ACNE SERIES PURIFIER CREAM- salicylic acid, sulfur cream

  • 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 8, 2020

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  • Drug Facts:

  • Active Ingredients

    Salicylic Acid : 2%

    Sulfur : 3%

  • Purpose

    Acne treatment

  • Use

    Moisturizer for acneic skin.

  • 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 rash occurs, 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.

  • Directions

    • Apply to clean face at night. • Repeat use every other day for the first 15 days, then use every night. • A tingling effect may occur during application.

  • Additional Information

    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.  

  • Inactive Ingredients

    Water\Aqua\Eau, Glycolic Acid, Caprylic/Capric Triglyceride, Glycerin, Azelaic Acid, Peg-120 Methyl Glucose Dioleate, Sorbitol, Butylene Glycol, Niacinamide, Cetearyl Olivate, Cetearyl Alcohol, Cetyl Alcohol, Hexyl Laurate, Ammonium Hydroxide, Carbomer, Stearic Acid, Dimethicone, Sorbitan Olivate, Glyceryl Stearate, Peg-100 Stearate, Laureth-12, Polysilicone-11, Phenoxyethanol, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Olea Europaea (Olive) Leaf Extract, Peg-30 Castor Oil, Xanthan Gum, Caprylyl Glycol, Lysolecithin, Sodium Hyaluronate, Hydrolyzed Glycosaminoglycans, Perilla Ocymoides (Beefsteak Plant) Seed Oil, Arctostaphylos Uva Ursi Leaf Extract, Disodium EDTA,  Ethylhexylglycerin, Magnesium Aluminum Silicate

  • SPL UNCLASSIFIED SECTION

    clarify with ACNE series

    SALICYLIC ACID

    SULFUR

    NIACINAMIDE

    AZELAIC ACID

    BEAUTY CARE

    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

    (FOR ACNE SKIN)

    Formulated with AHAs & BHAs to exfoliate and repair acne.

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    CELESTY  ACNE SERIES PURIFIER CREAM
    salicylic acid, sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SORBITOL (UNII: 506T60A25R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    AMMONIA (UNII: 5138Q19F1X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LAURETH-12 (UNII: OAH19558U1)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    PEG-30 CASTOR OIL (UNII: GF873K38RZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-104-011 in 1 BOX12/07/2020
    160 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(81120-104)
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