FDA Label for Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid

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Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid Product Label

The following document was submitted to the FDA by the labeler of this product Amcol Health & Beauty Solutions, Inc. Dba. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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HBS Code (Labeler): FP40901-30.2

Distributor: CVS Pharmacy, Inc.

Human OTC Drug

Active Ingredients: Salicylic Acid 2%

CARTON TEXT

________________________________________________________

SKIN+PHARMACY

ADVANCED ACNE THERAPY

OVERNIGHT SALICYLIC ACID LOTION with Microsponge® Technology

Maximum Strength 2% Salicylic Acid

  • works overnight to help eliminate existing blemishes
  • helps prevent new breakouts from forming
  • contains anti-inflammatory Bisabolol & soothing Ale Vera to calm skin
  • fragrance- & oil-free formula
  • DERMATOLOGIST TESTED

    exclusively at CVS/pharmacy

    Actual Size Product on Side Panel

    1 FL OZ (30 mL)

    The advanced Overnight Salicylic Acid Lotion is formulated with Microsponge® technology, which is specially designed to promote healthy, visibly clear skin. This sustained-release acne-fighting technology helps reduce irritation by continuously working overnight, providing efficacy as it gently soothes and moisturizes skin, without clogging pores. Maximum strength salicylic acid exfoliates as it works to help clear existing acne and prevent new breakouts from forming. This unique formula contains anti-inflammatory Bisabolol, and Aloe Vera to help soothe, calm and condition skin.

    Key Benefits:

    • helps eliminate existing blemishes
    • helps prevent new breakouts from forming
    • soothing, oil-free formula
    • unclogs pores
    • fragrance free
    • Daily Regiment:

      For best results, use this product with the full Skin+Pharmacy Advanced Acne Therapy regimen.

      • Cleanse
        Clarifying Daily Cleanser Gentle Exfoliating Scrub
      • Moisturize
        Active Clearing Lotion
      • Treat
        Spot Treatment
        Targeted Treatment Wipes
        Overnight Salicylic Acid Lotion
        Mattifying Lotion
      • Warning: This product contains a chemical known to the State of California to cause cancer.

        Skin+Pharmacy Advanced Acne Therapy is an innovative line of clinically tested skin care products that help reduce the appearance of acne. These products, exclusive to CVS/pharmacy, are less irritating to skin, yet powerful enough to treat breakouts and unclog pores. Let Skin+Pharmacy help improve your appearance toward a clear, acne-free complexion.

        Actual Size

        Drug Facts


Active Ingredient



Salicylic Acid 2%


Purpose



Acne treatment


Use



for the management of acne


Warnings



For external use only


When Using This Product



  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid contact with eyes. If contact occurs, flush thoroughly with water

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Clean the skin thoroughly before applying this product.
  • Apply a thin layer to affected area once a day before bedtime.
  • If bothersome dryness or peeling occurs, reduce application to every other day.
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.

Inactive Ingredients



Water, Ethoxydiglycol, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, PEG-8, Laureth-4, Dimethicone, Aloe Barbadensis Leaf Juice, Polysorbate 80, DEA-Cetyl Phosphate, Polyacrylamide, Propylene Glycol, Sodium Citrate, Bisabolol, C13-14 Isoparaffin, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling since all warnings are not included on the inner package.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2014 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in the U.S.A. of U.S. and foreign components
V-13649

CVS® Quality
Money Back Guarantee

PLEASE RECYCLE

V-31490

#987593

FP409

M050790

________________________________________________________

end of text

160611

AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com

[email protected]


Principal Display Panel - 20 G/2 Ml Carton Label



SKIN +
PHARMACY

ADVANCED
ACNE
THERAPY

OVERNIGHT
SALICYLIC ACID
LOTION

with Microsponge*
Technology

Maximum Strength
2% Salicylic Acid

  • works overnight to help
    eliminate existing blemishes
  • helps prevent new
    breakouts from forming
  • contains anti-inflammatory
    Bisabolol & soothing
    Aloe Vera to calm skin
  • fragrance- &
    oil-free formula
  • exclusively at

    CVS/pharmacy

    Actual Size Product on Side Panel

    1 FL OZ (30 mL)


Principal Display Panel - 20 G/2 Ml Tube Label



SKIN +
PHARMACY

ADVANCED
ACNE
THERAPY

OVERNIGHT
SALICYLIC ACID LOTION

with Microsponge* Technology

Maximum Strength
2% Salicylic Acid

* Please review the disclaimer below.