Label: CLEAR UP CONTROL SOLUTION ANTI-BLEMICHES- 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 June 29, 2010

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  • ACTIVE INGREDIENT

    Salicylic Acid 2% w/w.

    INACTIVE INGREDIENTS

    WATER/EAU • ETHOXYDIGLYCOL • GLYCOLIC ACID • METHYL GLUCETH 20 • SODIUM CITRATE • GLYCERIN •
    PEG-40 HYDROGENATED CASTOR OIL • SODIUM HYDROXIDE • AMYLOPECTIN • DEXTRIN • LACTIC ACID* • XANTHAN GUM •
    BUTYLENE GLYCOL • ARGININE* • CELLULOSE GUM • PEG-60 ALMOND GLYCERIDES • CAPRYLYL GLYCOL • ALLANTOIN •
    CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL • ALMOND (PRUNUS AMYGDALUS DULCIS) OIL • ROSEMARY (ROSMARINUS
    OFFICINALIS) OIL • SAGE (SALVIA OFFICINALIS) OIL SPANISH • LAVANDIN (LAVANDULA LATIFOLIA) OIL •
    COLEUS FORSKOHLII OIL • GALANGAL (KAEMPFERIA GALANGA) EXTRACT • CHAMOMILE (ANTHEMIS NOBILIS) OIL •
    CARBOMER • NORDIHYDROGUAIARETIC ACID • OLEANOLIC ACID • ETHYLHEXYL GLYCERIN • PHENOXYETHANOL

    For the treatment of acne.Reduces the number of acne pimples,blackheads and whiteheads and allows skin to heal.

    DIRECTIONS

    Morning and evening, first
    cleanse the skin thoroughly with CLEAR UP
    Cleansing Gel. Then apply a thin layer
    of CLEAR UP Control Solution Anti-Blemishes
    to the entire face and other affected areas
    one to three times daily, or as directed by a
    doctor. Massage in with light effleurages.
    Then apply CLEAR UP Anti-Shine Moisturizer
    SPF 15. 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.

    WARNINGS

    For external use only. Using
    other topical acne medications at the same
    time or immediately following use of this
    product may increase dryness or irritation of
    the skin. If this occurs, only one medication
    should be used unless directed by a doctor.
    Avoid direct contact with the eyes. If product
    gets into the eyes, rinse liberally with water.
    Discontinue use if skin irritation develops
    or increases. If irritation persists, consult a
    doctor. This product contains alpha-hydroxyacids
    (AHA) which may increase sensitivity
    to the sun and lead to skin burn. Reduce sun
    exposure and use a sunblock during the use
    of this product and the week following its use.

  • PRINCIPAL DISPLAY PANEL

    image of tube 50ml lable
    image of tube 50ml lable

    image of tube 15 ml lable
    image of tube 15 ml lable

    image of carton 50ml label
    image of carton 50ml lable


    Enter section text here

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • INGREDIENTS AND APPEARANCE
    CLEAR UP CONTROL SOLUTION ANTI-BLEMICHES 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-392
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    AMYLOPECTIN (UNII: 4XO4QFV777)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SAGE OIL (UNII: U27K0H1H2O)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    Product Characteristics
    Colorblue (DRAK BLEU) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62499-392-111 in 1 CARTON
    1NDC:62499-392-0450 g in 1 TUBE
    2NDC:62499-392-121 in 1 KIT
    2NDC:62499-392-0615 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/29/2010
    Labeler - Laboratoire Dr. Renaud (202501565)
    Registrant - Laboratoire Dr. Renaud (202501565)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Dr. Renaud202501565manufacture
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