ACNE SPOT TREATMENT- benzoyl peroxide 10% cream 
CVS

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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Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne treatment

Uses

For the treatment of acne.

Warnings

For external use only.

Do not use

  • if you have very sensitive skin or are sensitive to Benzoyl Peroxide

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.
  • rinse right away with water if it gets in eyes.
  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with eyes, lips, and mouth.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop and ask a doctor if

  • irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Aluminum hydroxide, Bentonite, Carbomer, Glyceryl Stearate SE, Isopropyl myristate, Methylparaben, PEG-12, Potassium Hydroxide, Propylene Glycol, Propylparaben, Water

CVS Acne Spot Treatment

Maximum Strength

10% Benzoyl Peroxide

image descriptionimage description

ACNE SPOT TREATMENT 
benzoyl peroxide 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-243
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BENTONITE (UNII: A3N5ZCN45C)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-243-011 in 1 CARTON10/31/2014
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/31/2014
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(59779-243) , label(59779-243)

Revised: 12/2017
Document Id: 44cf0d45-b136-4945-8b34-7e77f9cd71fc
Set id: bb09fe74-69aa-4a8f-aaff-c333cea74e82
Version: 2
Effective Time: 20171226
 
CVS