Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask Liquid
FDA Label NDC 68634-058

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amcol Health & Beauty Solutions, Inc. Dba for the product Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask (NDC 68634-058). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

HBS Code (Labeler): FP41901-99.1

Distributor: CVS Pharmacy, Inc.

Human OTC Drug

Active Ingredients: Salicylic Acid 0.5%

CARTON TEXT

________________________________________________________

SKIN+PHARMACY

ADVANCED ACNE THERAPY

PORE REFINING SKIN MASK with Microsponge® Technology

0.5% Salicylic Acid

  • contains anti-inflammatory Bisabolol & Vitamins A & E
  • helps eliminate & prevent blemishes
  • unclogs pores
  • fragrance & oil-free formula

    • DERMATOLOGIST TESTED

    exclusively at CVS/pharmacy

    Actual Product Size on Side Panel

    3.3 FL OZ (99 mL)

    The advanced Pore Refining Facial Mask is formulated with Microsponge® technology, which is specially designed to promote healthy, visibly clear skin. This sustained-release acne-fighting technology helps reduce irritation while Salicylic Acid exfoliates to help clear existing acne and prevent new breakouts from forming. This mask contains Kaolin and Bentonite Clay to help draw out dirt and impurities combined with anti-inflammatory Bisabolol and antioxidants to help provide free radical protection, leaving your skin feeling clean, smooth, and refreshed with continued use.

    Key Benefits:

    • helps eliminate existing blemishes
    • helps prevent new breakouts from forming
    • unclogs pores
    • oil-free formula
    • fragrance free

      • Daily Regimen:

      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
        Pore Refining Facial Mask
        Spot Treatment
        Targeted Treatment Wipes
        Salicylic Acid Lotion
        Mattifying Lotion

        • 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 0.5%

Purpose

Acne

Use

for the management of acne

Warnings

For external use only

When Using This Product

  • 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 contact with eye. if contact occurs, flush thoroughly with water.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

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

  • Once to twice per week, apply a generous layer evenly onto cleansed skin avoiding the eye area.
  • Leave on for 10 minutes.
  • Follow with your favorite Skin+Pharmacy moisturizer.

Inactive Ingredients

Water, Kaolin, Glycerin, Bentonite, Butylene Glycol, Cetearyl Alcohol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cocamidopropyl Betaine, PEG-100 Stearate, Magnesium Aluminum Silicate, Glyceryl Stearate, Phenoxyethanol, Ceteareth-20, Xanthan Gum, Chlorphenesin, Caffeine, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Sodium Hydroxide, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Bisabolol.

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

© 2016 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

M050873CP
FP419
#742825

________________________________________________________

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 - 5 G/2 Ml Carton Label

SKIN +
PHARMACY

ADVANCED
ACNE
THERAPY

PORE REFINING
FACIAL MASK

with Microsponge*
Technology

0.5% Salicylic Acid

  • contains anti-inflammatory
    Bisabolol & Vitamins A & E
  • helps eliminate & prevent
    blemishes
  • unclogs pores
  • fragrance- & oil-free formula

    • exclusively at

    CVS/pharmacy

    Actual Size Product
    on Side Panel

    3.3 FL OZ (99 mL)

    Principal Display Panel (5 g/2 mL Carton Label)

    Principal Display Panel (5 g/2 mL Carton Label)

Principal Display Panel - 5 G/2 Ml Tube Label

SKIN +
PHARMACY

ADVANCED
ACNE
THERAPY

PORE REFINING
FACIAL MASK

with Microsponge*
Technology

0.5% Salicylic Acid

  • contains anti-inflammatory
    Bisabolol & Vitamins A & E
  • helps eliminate & prevent
    blemishes
  • unclogs pores
  • fragrance- & oil-free formula

    • exclusively at

    CVS/pharmacy

    Actual Size Product
    on Side Panel

    3.3 FL OZ (99 mL)

    Principal Display Panel (5 g/2 mL Tube Label)

    Principal Display Panel (5 g/2 mL Tube Label)

* Please review the disclaimer below.