Label: PRO CLEAR SERUM- salicylic acid acne treatment liquid

  • Category: HUMAN OTC DRUG LABEL

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 July 1, 2021

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  • Active ingredient

    Salicylic acid 2.0%

  • Purpose

    • Acne medication
  • Uses

    • For the treatment of acne
  • Warnings

    For external use only

  • 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.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below
    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a layer one to three times daily
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Inactive ingredients

    water, glycolic acid, lactic acid, phellendron amurense bark extract, pear juice ferment filtrate, rehmannia chinensis root extract, melia azadirachta leaf extract, scutellaria baicalensis root extract, houttuynia cordata extract, niacinimide

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

    RELUMINS

    PRO CLEAR SERUM

    Advanced Botanical Formula with 2% Salicylic Acid

    Complete Facial Care For Blemish-Prone Skin

    Penetrates Deep • Promotes Clear Skin

    PROFESSIONAL SKIN CARE

    1.7 fl oz (50 ml)

    EXP:

    LOT:

    Relumins Labs

    USA

    183 Locust Ave

    West Long Branch, NJ 07764

    www.relumins.com

    otc-bottle-label

    Carton Label

    RELUMINS

    PRO CLEAR FOAM

    Advanced Botanical Formula with 2% Salicylic Acid

    Complete Facial Care For Blemish-Prone Skin

    Penetrates Deep • Promotes Clear Skin

    PROFESSIONAL SKIN CARE

    1.7 fl oz (50 ml)

    EXP:

    LOT:

    Relumins Labs

    USA

    183 Locust Ave

    West Long Branch, NJ 07764

    www.relumins.com

    carton-label

  • INGREDIENTS AND APPEARANCE
    PRO CLEAR SERUM 
    salicylic acid acne treatment liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79061-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    PEAR JUICE (UNII: F214DLA9BE)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79061-040-011 in 1 CARTON05/21/2021
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/31/2018
    Labeler - Relumins Labs LLC (081506626)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMESTHETIC LABS. CORP.725862577MANUFACTURE(79061-040)