Label: SEBOBALANCE SPOT CONTROL- 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 30, 2010

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  • ACTIVE INGREDIENT

    Salicylic Acid 1% w/w.

    INACTIVE INGREDIENTS

    WATER/EAU • ALCOHOL DENAT • SORBITOL • METHYL GLUCETH 20 • GLYCOLIC ACID • GLYCERIN •
    ALPHA-GLUCAN OLIGOSACCHARIDE • SODIUM CITRATE • BUTYLENE GLYCOL • PROPYLENE GLYCOL • SODIUM HYDROXIDE • AMYLOPECTIN • XANTHAN GUM • DEXTRIN • HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT • ARGININE • CELLULOSE GUM • ALLANTOIN • PEUMUS BOLDUS LEAF EXTRACT • ASCOPHYLLUM NODOSUM EXTRACT • ANTHEMIS NOBILIS FLOWER EXTRACT • CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT • CENTAUREA CYANUS FLOWER EXTRACT • TILIA VULGARIS FLOWER EXTRACT • CALENDULA OFFICINALIS FLOWER EXTRACT • HYPERICUM PERFORATUM EXTRACT • ASPARAGOPSIS ARMATA EXTRACT • ETHYLHEXYLGLYCERIN • PHENOXYETHANOL •

    For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to heal.

    DIRECTIONS

    Morning and evening, after a thorough cleansing of the skin, apply SeboBalance Spot Control
    Gel locally on cutanous imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.

    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-hydroxy-acids (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 carton label

    image of carton label


    Image of bottle label
    image of bottle label

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • INGREDIENTS AND APPEARANCE
    SEBOBALANCE SPOT CONTROL  
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-384
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    AMYLOPECTIN (UNII: 4XO4QFV777)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ASPARAGOPSIS ARMATA (UNII: 2936KN6I1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62499-384-111 in 1 CARTON
    1NDC:62499-384-078 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/30/2010
    Labeler - Laboratoire Dr. Renaud (202501565)
    Registrant - Laboratoire Dr. Renaud (202501565)
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