SKINPHARMACY ADVANCED ACNE THERAPY ACTIVE CLEARING- benzoyl peroxide liquid

SkinPharmacy Advanced Acne Therapy Active Clearing by

Drug Labeling and Warnings

SkinPharmacy Advanced Acne Therapy Active Clearing by is a Otc medication manufactured, distributed, or labeled by CVS Health, AMCOL Health & Beauty Solutions, Inc. DBA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Use

• For the management of acne

Warnings

For external use only

Do not use this medication if you

• Have very sensitive skin
• Are sensitive to benzoyl peroxide

When using this product

• Avoid unnecessary sun exposure and use a sunscreen after using this product.
• Avoid contact with lips, eyes, or mouth.
• If product gets into the eyes rinse thoroughly with water.
• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
• Avoid contact with hair and dyed fabrics, which may be bleached by this product.
• In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop use and ask a doctor if irritation becomes severe.

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

Directions

• Clean skin thoroughly before applying this product.
• Apply a thin layer to affected area one to two times per day.
• 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.

Inactive ingredients

Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cetyl Alcohol, Sorbitol, Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, 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 imported components V-31490

CVS® Quality

Money Back Guarantee

#971014

M050733

FP407

Principal Display Panel - Carton Label

SKIN+
PHARMACY

ADVANCED
ACNE
THERAPY

ACTIVE CLEARING LOTION
with Microsponge® Technology

2.5% Benzoyl Peroxide

• clinically proven to kill acne-causing bacteria
• clinically proven to effectively reduce inflammatory lesions
• soothing, oil-free formula
• unclogs pores
• fragrance free

DERMATOLOGIST TESTED

exclusively at
CVS/pharmacy

1 FL OZ (30 mL)

Principal Display Panel - Tube Label

SKIN+PHARMACY

ADVANCED
ACNE
THERAPY

ACTIVE CLEARING LOTION
with Microsponge® Technology

2.5% Benzoyl Peroxide

• clinically proven to kill acne-causing bacteria
• clinically proven to effectively reduce inflammatory lesions
• soothing, oil-free formula
• unclogs pores
• fragrance free

DERMATOLOGIST TESTED

exclusively at
CVS/pharmacy

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

SKINPHARMACY ADVANCED ACNE THERAPY ACTIVE CLEARING 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM)	benzoyl peroxide	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
cetyl alcohol (UNII: 936JST6JCN)
sorbitol (UNII: 506T60A25R)
glyceryl dilaurate (UNII: MFL3ZIE8SK)
stearyl alcohol (UNII: 2KR89I4H1Y)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
sodium citrate (UNII: 1Q73Q2JULR)
silicon dioxide (UNII: ETJ7Z6XBU4)
sodium lauryl sulfate (UNII: 368GB5141J)
citric acid monohydrate (UNII: 2968PHW8QP)
methylparaben (UNII: A2I8C7HI9T)
xanthan gum (UNII: TTV12P4NEE)
propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-076-01	1 in 1 CARTON	06/01/2014
1		30 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	06/01/2014

Labeler - CVS Health (062312574)

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

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(69842-076) , PACK(69842-076) , LABEL(69842-076) , ANALYSIS(69842-076)