CVS ADVANCE ACNE THERAPY KIT- salicylic acid, benzoyl peroxide 
Diversified Global Technologies, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Advance Acne Therapy Kit

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:

Kit

Package Labeling:

Label118

Package Labeling:

Label12

Package Labeling:

Label22

CVS ADVANCE ACNE THERAPY KIT 
salicylic acid, benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42877-003
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42877-003-011 in 1 KIT; Type 0: Not a Combination Product01/19/201706/11/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 118 mL
Part 21 TUBE 12 mL
Part 31 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42877-004-04118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/18/201706/11/2020
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42877-005-1212 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/18/201706/11/2020
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42877-006-2222 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/18/201706/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/18/201706/11/2020
Labeler - Diversified Global Technologies, LLC (621539352)
Establishment
NameAddressID/FEIBusiness Operations
AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care872684803manufacture(42877-003, 42877-004, 42877-005, 42877-006)

Revised: 10/2020
 
Diversified Global Technologies, LLC