Drug Facts

Active Ingredient

2% Salicylic Acid

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 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 a 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.

M050775

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Carton Label

SKIN+PHARMACY

ADVANCED
ACNE THERAPY KIT

DERMATOLOGIST TESTED

BONUS:

Includes 2 Gentle Facial

Cleansing Sponges

exclusively at
CVS/pharmacy

$35 VALUE

$19.99

ONE MONTH SUPPLY

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit 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

4 FL OZ (118 mL)

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit 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

0.75 FL OZ (22 mL)

Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label

SKIN+PHARMACY

ADVANCED
ACNE
THERAPY

SPOT TREATMENT
with Microsponge® Technology

5% Benzoyl Peroxide

clinically proven to effectively reduce inflammatory lesions
effectively kills acne-causing bacteria
helps reduce irritation
fragrance free

DERMATOLOGIST TESTED

exclusively at
CVS/pharmacy

0.4 FL OZ (12 mL)

SKIN PHARMACY ADVANCED ACNE THERAPY KIT
salicylic acid, benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68634-067

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68634-067-01	1 in 1 CARTON; Type 0: Not a Combination Product	10/01/2014

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	118 mL
Part 2	1 TUBE	22 mL
Part 3	1 TUBE	12 mL

Part 1 of 3

SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER
salicylic acid liquid

Product Information
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/01/2014

Part 2 of 3

SKIN PHARMACY ADVANCED ACNE THERAPY ACTIVE CLEARING
benzoyl peroxide lotion

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM)	benzoyl peroxide	25 g in 2 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		22 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/01/2014

Part 3 of 3

SKIN PHARMACY ADVANCED ACNE THERAPY SPOT TREATMENT
benzoyl peroxide lotion

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM)	benzoyl peroxide	50 g in 2 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		12 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/01/2014

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

Name	Address	ID/FEI	Business Operations
Establishment
AMCOL Household & Personal Care		872684803	MANUFACTURE(68634-067) , PACK(68634-067) , LABEL(68634-067) , ANALYSIS(68634-067)