SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID- salicylic acid liquid

SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID by

Drug Labeling and Warnings

SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 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]

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

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

CVS® Quality

Money Back Guarantee

V-13649

PLEASE RECYCLE

V-31490

#987593

FP409

M050790

Principal Display Panel - Carbon 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 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)

Principal Display Panel - Tube 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

DERMATOLOGIST TESTED

exclusively at
CVS/pharmacy

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-066
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 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
LAURETH-4 (UNII: 6HQ855798J)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
LEVOMENOL (UNII: 24WE03BX2T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-066-01	1 in 1 CARTON	05/01/2014
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	05/01/2014

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	ANALYSIS(69842-066) , MANUFACTURE(69842-066) , LABEL(69842-066) , PACK(69842-066)