SKIN PHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK- salicylic acid liquid

SKIN PHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK by

Drug Labeling and Warnings

SKIN PHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK by is a Otc medication manufactured, distributed, or labeled by AMCOL Health & Beauty Solutions, Inc. DBA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

1. Cleanse
   Clarifying Daily Cleanser
   Gentle Exfoliating Scrub
2. Moisturize
   Active Clearing Lotion
3. 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.

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

lauren.haase@mineralstech.com

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 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)

INGREDIENTS AND APPEARANCE

SKIN PHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	5 g  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
kaolin (UNII: 24H4NWX5CO)
glycerin (UNII: PDC6A3C0OX)
bentonite (UNII: A3N5ZCN45C)
butylene glycol (UNII: 3XUS85K0RA)
cetostearyl alcohol (UNII: 2DMT128M1S)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
peg-100 stearate (UNII: YD01N1999R)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
glyceryl monostearate (UNII: 230OU9XXE4)
phenoxyethanol (UNII: HIE492ZZ3T)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
xanthan gum (UNII: TTV12P4NEE)
chlorphenesin (UNII: I670DAL4SZ)
caffeine (UNII: 3G6A5W338E)
ethylhexylglycerin (UNII: 147D247K3P)
edetate disodium (UNII: 7FLD91C86K)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium hydroxide (UNII: 55X04QC32I)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
vitamin a palmitate (UNII: 1D1K0N0VVC)
ascorbyl palmitate (UNII: QN83US2B0N)
levomenol (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-058-01	1 in 1 CARTON	07/01/2016
1		99 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2016

Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(68634-058) , PACK(68634-058) , LABEL(68634-058) , ANALYSIS(68634-058)