Label: CELESTY ACNE SERIES CLARIFYING TREATMENT PADS- salicylic acid cloth

  • 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 9, 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. Helps prevent blackheads.

  • Warnings

    For external use only. Flammable. Keep away from fire and flame.

    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. Avoid contact with the eyes, lips, mouth. If contact occurs flush with water.

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

    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.

  • How to use

    Apply to the problematic area in the evening 1 up to 3 days a week depending on skin sensitivity. For the whole face peeling: Use once a week. Take one pad, swipe pad over clean face avoiding eye area. Wait about an hour. Apply a suitable moisturizer afterwards. For scalp: Apply once a week. Rub the pad on the entire scalp. Test a small amount against clean skin on forearm 24 hours prior to use.

  • Other Information

    Store in a dry, cool place. Keep jar tightly closed.

    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.

  • Inactive Ingredients

    Alcohol Denat., Water\Aqua\Eau, Glycerin, Glycolic Acid, PVP, Lactic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice, Allantoin, Ammonium Hydroxide.

  • SPL UNCLASSIFIED SECTION

    clarify with ACNE series

    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

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CELESTY  ACNE SERIES CLARIFYING TREATMENT PADS
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-101
    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
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    AMMONIA (UNII: 5138Q19F1X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-101-011 in 1 BOX12/07/2020
    125 in 1 JAR
    13 mL in 1 PACKAGE; 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(81120-101)