CVS ADVANCE ACNE THERAPY KIT- salicylic acid, benzoyl peroxide kit

CVS Advance Acne Therapy Kit by

Drug Labeling and Warnings

CVS Advance Acne Therapy Kit by is a Otc medication manufactured, distributed, or labeled by Diversified Global Technologies, LLC, AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CVS Advance Acne Therapy Clarifying Daily Cleanser with Polytrap Technology

Drug Facts

Active ingredient

2 % Salicylic Acid

Purpose

Acne Treatment

Use

• For the management of acne

Warnings

For external use only

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 docotor.

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 irrtiation occurs, only use 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 ingredient

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.

CVS Advance Acne Therapy Spot Treatment with Microsponge Technology

​Drug Facts

Active ingredient

Benzoyl Peroxude 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 senstive 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.

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.
• Cover the entire affected area with a thin layer one to three times daily 
• If going outside apply sunscreen after using this product and consult a physician. Keep tightly closed and avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive ingredients

Water, Glycerin, Methly Methacrylate/Glycol Dimethacrylate Crosspolymer, Sorbitol, Cetyl Alcohol, Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

CVS Advance Acne Therapy Active Clearing Lotion with Microsponge Technology

​Drug Facts

Active ingredient

Benzoyl Peroxude 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 senstive 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.

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, Methly 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.

Package Labeling:

Package Labeling:

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

CVS ADVANCE ACNE THERAPY KIT 
salicylic acid, benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42877-003

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42877-003-01	1 in 1 KIT; Type 0: Not a Combination Product	01/19/2017

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

Part 1 of 3

CVS ADVANCE ACNE THERAPY CLARIFYING DAILY CLEANSER WITH POLYTRAP TECHNOLOGY 
salicylic acid liquid

Product Information
Item Code (Source)	NDC: 42877-004
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)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42877-004-04	118 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	01/18/2017

Part 2 of 3

CVS ADVANCE ACNE THERAPY SPOT TREATMENT WITH MICROSPONGE TECHNOLOGY 
benzoyl peroxide cream

Product Information
Item Code (Source)	NDC: 42877-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SORBITOL (UNII: 506T60A25R)
CETYL ALCOHOL (UNII: 936JST6JCN)
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: 42877-005-12	12 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	01/18/2017

Part 3 of 3

CVS ADVANCE ACNE THERAPY ACTIVE CLEARING WITH MICROSPONGE TECHNOLOGY 
benzoyl peroxide lotion

Product Information
Item Code (Source)	NDC: 42877-006
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: 42877-006-22	22 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	01/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/18/2017

Labeler - Diversified Global Technologies, LLC (621539352)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care		872684803	manufacture(42877-003, 42877-004, 42877-005, 42877-006)