SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER- salicylic acid liquid

SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER by

Drug Labeling and Warnings

SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER 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): FP40604-5.1

Distributor: CVS Pharmacy, Inc.

Human OTC Drug

Active Ingredients: Salicylic Acid 2%

LABEL TEXT

________________________________________________________

SKIN+PHARMACY

ADVANCED ACNE THERAPY

CLARIFYING DAILY CLEANSER with Polytrap® Technology

Maximum Strength 2% Salicylic Acid

• removes excess skin oils
• unclogs pores
• oil-free formula

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

5 FL OZ (148 mL)

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, kill acne-causing bacteria, and unclog pores. Let Skin+Pharmacy help improve your appearance toward a clear, acne-free complexion.

The oil-free Clarifying Daily Cleanser is formulated with Polytrap®, a proven sebum oil absorber that can absorb up to 4 times its weight in skin oil. Maximum strength salicylic acid unclogs pores and deep cleans, leaving skin feeling refreshed. Use this product with the full Skin+Pharmacy Advanced Acne Therapy regimen.

Drug Facts

Active Ingredient

2% Salicylic Acid

Purpose

Acne

Uses for the management of acne

Warnings

For external use only

Do not use this medication if you

• Have very sensitive skin
• Are sensitive to salicylic acid

Ask a doctor or pharmacist before use if you are

Using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product

• Skin irritation and dryness are 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 the same time.
• When using this product avoid contact with eyes. If this occurs, immediately flush with water.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center right away.

Directions

• Use morning and night.
• Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes.
• Rinse thoroughly with warm water. Pat dry.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside use sunscreen.

Inactive ingredients

Water, Sodium C14-16 Olefin Sulfonate, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, DMDM Hydantoin, Disodium EDTA, Tocopheryl Acetate, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Yellow 5, Red 40, Fragrance.

Polytrap® 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 imported components

V-31490

M050731

CVS® Quality

Money Back Guarantee

#971009

FP406

________________________________________________________

end of text

160913

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

Principal Display Panel - Carton Label

SKIN+PHARMACY

ADVANCED
ACNE THERAPY

CLARIFYING
DAILY CLEANSER
with Polytrap® Technology

Maximum Strength 2% Salicylic Acid

• removes excess skin oils
• unclogs pores
• oil-free formula

DERMATOLOGIST TESTED

exclusively at
CVS/pharmacy

5 FL OZ (148 mL)

INGREDIENTS AND APPEARANCE

SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	20 g  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U)
polyethylene glycol 4000 (UNII: 4R4HFI6D95)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
Xanthan gum (UNII: TTV12P4NEE)
DMDM Hydantoin (UNII: BYR0546TOW)
edetate disodium (UNII: 7FLD91C86K)
.alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)
Hamamelis virginiana flower water (UNII: 222MYC9QUV)
Butylene glycol (UNII: 3XUS85K0RA)
Calendula Officinalis flower (UNII: P0M7O4Y7YD)
licorice (UNII: 61ZBX54883)
Phenoxyethanol (UNII: HIE492ZZ3T)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
FD&C red no. 40 (UNII: WZB9127XOA)
Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer (UNII: EX0F4CZ66H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-064-01	148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(68634-064) , PACK(68634-064) , LABEL(68634-064) , ANALYSIS(68634-064)