Label: SEPHORA ACNE-FIGHTING ROLL-ON - salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • SEPHORA Acne-Fighting Roll-On Gel
  • ACTIVE INGREDIENT

    Salicylic Acid  2%

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  • Purpose

    Acne Treatment

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  • Use

    For the treatment of acne.

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  • Warnings

    For external use only.

    When using this product

    • skin irritation and dryness in more likely 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 Poison Control center right away.

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  • Directions

    • 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.
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  • Inactive Ingredients

    water, alcohol, acrylamide/sodium acryloyldimethyltaurate copolymer, c13-13 isoparaffin, peg-40 hydrogenated castor oil, phenoxyethanol, glycerin, laureth-7, fragrance, butylenes glycol, sodium hydroxide, panthenol, licorice (glycyrrhiza glabra) root extract, senna (cassia angustifolial) seed polysaccharide.

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  • SPL UNCLASSIFIED SECTION

    WHY WE LOVE IT

    • formulated without parabens.  Non-comodogenic and dermatologically tested, suits even sensitive skin
    • contains salicylic acid to purify skin and reduce breakouts after the 1st application.  Contains HydroSenn+TM, an ultra moisturizing ingredient to keep skin from drying out.
    • roll-on applicator allows ultra targeted application on acne spots.  Slip it into a purse and take it everywhere!  Morning and night, apply directly on breakouts.  Rub the gel with roll-on applicator.
    DEMONSTRATED RESULTS!
    After 8 hours:
    • reduction of the size of acne breakouts by 60%(1)
    After 28 days:
    Women noticed
    • reduction of the number of acne spots: 70% (2)
    • breakouts disappeared without leaving marks:  74% (2)
    (1) Scientific test on 22 volunteers,
    (2) % of users satisfied.  In use test on 22 volunteers.

    S+, 70 Avenue des Champs-Elysees, F-75008 Paris, France, Dist. by Sephora USA, 525 Market Street, 32nd Floor, San Francisco, CA 94105.  made in France.
    To report a serious adverse event, contact Sephora USA.


    100%  Gentle
    • formulated without parabens
    • suits all skin types, even sensitive skin
    Effective
    • HydroSenn+TM: an ultra moisturizing natural ingredient that is more effective than hyaluronic acid
    • clinically tested by independent laboratories.
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  • PRINCIPAL DISPLAY PANEL

    SEPHORA   Roll-on stop acne  Acne-fighting roll-on gel   spot be gone   Acne Treatment  2% Salicylic Acid   1 problem: 1 solution     Dermatologically tested   10ml 0.33 fl. oz.

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  • SEPHORA Acne-Fighting Roll-On Gel 10ml (31720-203-06)
  • INGREDIENTS AND APPEARANCE
    SEPHORA ACNE-FIGHTING ROLL-ON  
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:31720-203
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    C13-14 ISOPARAFFIN  
    POLYOXYL 40 HYDROGENATED CASTOR OIL  
    PHENOXYETHANOL  
    GLYCERIN  
    LAURETH-7  
    BUTYLENE GLYCOL  
    SODIUM HYDROXIDE  
    PANTHENOL  
    GLYCYRRHIZA GLABRA  
    SENNA ALEXANDRINA SEED  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:31720-203-06 10 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 11/12/2012
    Labeler - S+ (572406531)
    Registrant - S+ (572406531)
    Establishment
    Name Address ID/FEI Business Operations
    INTERCOSMETIQUES 390266153 manufacture(31720-203)
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