SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID- salicylic acid liquid

SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID by

Drug Labeling and Warnings

SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 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): FP40901-30.2

Distributor: CVS Pharmacy, Inc.

Human OTC Drug

Active Ingredients: Salicylic Acid 2%

CARTON TEXT

________________________________________________________

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)

The advanced Overnight Salicylic Acid Lotion is formulated with Microsponge® technology, which is specially designed to promote healthy, visibly clear skin. This sustained-release acne-fighting technology helps reduce irritation by continuously working overnight, providing efficacy as it gently soothes and moisturizes skin, without clogging pores. Maximum strength salicylic acid exfoliates as it works to help clear existing acne and prevent new breakouts from forming. This unique formula contains anti-inflammatory Bisabolol, and Aloe Vera to help soothe, calm and condition skin.

Key Benefits:

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

Daily Regiment:

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
   Spot Treatment
   Targeted Treatment Wipes
   Overnight Salicylic Acid Lotion
   Mattifying Lotion

Warning: This product contains a chemical known to the State of California to cause cancer.

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 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
V-13649

CVS® Quality
Money Back Guarantee

PLEASE RECYCLE

V-31490

#987593

FP409

M050790

________________________________________________________

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 - 20 g/2 mL Carton 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

exclusively at

CVS/pharmacy

Actual Size Product on Side Panel

1 FL OZ (30 mL)

Principal Display Panel - 20 g/2 mL 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

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-057
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)
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: 68634-057-01	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 - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	MANUFACTURE(68634-057) , PACK(68634-057) , LABEL(68634-057) , ANALYSIS(68634-057)