Label: CLEAR UP CLEANSING- 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 28, 2010

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  • ACTIVE INGREDIENT

    Salicylic Acid 2 % w/w

    INACTIVE INGREDIENTS

    WATER/EAU • COCAMIDOPROPYL BETAINE •
    TRIETHANOLAMINE • BUTYLENE GLYCOL • DISODIUM LAURETH SULFOCCINATE •
    METHYL GLUCETH-20 • GLYCERIN • COCAMIDE MEA • PEG-40 HYDROGENATED
    CASTOR OIL • GLYCOLIC ACID • SODIUM COCOYL ISETHIONATE •
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER • 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 • ALLANTOIN • PHENOXYETHANOL • XANTHAN GUM •
    CARBOXYMETHYLCELLULOSE • ETHYLHEXYL GLYCERIN • TETRASODIUM EDTA

    For the treatment of acne. Helps clear acne blemishes and allows skin to heal.

    DIRECTIONS

    Morning and evening, moisten
    the skin and apply a small quantity of CLEAR UP
    Cleansing Gel to the forehead, the cheeks, the chin,
    the neck and décolleté and massage gently with
    fi ngertips, insisting on the T zone (forehead, nose,
    chin), while avoiding the eye contour.
    Add a little lukewarm water and lather.
    Rinse thoroughly fi rst with lukewarm water,
    then with cold. Dry skin gently.
    N.B.: You may also work the Cleansing Gel
    into a lather with a little water in the palm
    of the hand before applying.

    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.
  • PRINCIPAL DISPLAY PANEL


    image of carton 200ml label
    image of carton 200ml label
    image of tube 60 ml label
    image of tube 60 ml label
    image of tube 200ml label
    image of tube 200 ml label


    Enter section text here

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • INGREDIENTS AND APPEARANCE
    CLEAR UP CLEANSING 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-394
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM GLYCOLATE (UNII: B75E535IMI)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SAGE OIL (UNII: U27K0H1H2O)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Product Characteristics
    Colorblue (dark blue) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62499-394-111 in 1 BOX
    1NDC:62499-394-09200 g in 1 TUBE
    2NDC:62499-394-121 in 1 KIT
    2NDC:62499-394-0860 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/28/2010
    Labeler - Laboratoire Dr. Renaud (202501565)
    Registrant - Laboratoire Dr. Renaud (202501565)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Dr. Renaud202501565manufacture
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