Label: CLEAR UP PREP- 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 July 1, 2010

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  • ACTIVE INGREDIENT

    Salicylic Acid 2% w/w.

    INACTIVE INGREDIENTS

    WATER • SORBITOL • ETHOXYDIGLYCOL • GLYCOLIC ACID • METHYL GLUCETH-20 • SODIUM CITRATE • GLYCERIN • LACTIC ACID • SODIUM HYDROXIDE • CELLULOSE GUM • XANTHAN GUM • ETHYLHEXYLGLYCERIN • PROPYLENE GLYCOL • PHENOXYETHANOL • CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT • HEDERA HELIX (IVY) EXTRACT • SAPONARIA OFFICINALIS EXTRACT •
    ARCTIUM LAPPA ROOT EXTRACT • SALVIA OFFICINALIS (SAGE) LEAF EXTRACT •

    DIRCETIONS

    Cover the eyes with cotton pads soaked in Blue Water. With the fingertips, apply evenly to the face and neck CLEAR UP Prep Lotion, making sure to avoid the lips.

    Application: 2-3 minutes | Pause: 7-8 minutes

    WARNINGS

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  • PRINCIPAL DISPLAY PANEL

    image of carton label
    image of carton label

    image of tube 5ml label
    image of tube5ml label

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • PURPOSE

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  • INGREDIENTS AND APPEARANCE
    CLEAR UP PREP 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-395
    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)  
    SORBITOL (UNII: 506T60A25R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LEMON OIL (UNII: I9GRO824LL)  
    SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    SAGE OIL (UNII: U27K0H1H2O)  
    Product Characteristics
    Colorblue (dark bleu) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62499-395-111 in 1 CARTON
    1NDC:62499-395-105 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/01/2010
    Labeler - Laboratoire Dr. Renaud (202501565)
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