MAXIMUM STRENGTH ACNE SPOT TREATMENT CVS HEALTH- 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              Purpose
Benzoyl Peroxide 10%....Acne Treatment

Use • 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
the 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, or possibly
swelling. Irritation may be reduced by
using the product less frequently or in a
lower concentration.
Stop use and ask a doctor if skin
irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions • cleanse the skin
thoroughly before applying medication
• cover the entire affected area with a thin
layer one to three times a 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. • if going
outside, use a sunscreen. Allow product to
dry, then follow direction in the sunscreen
labeling. If sensitivity develops, discontinue
use of both products and consult a doctor.

Inactive ingredients
Aluminum Hydroxide,
Bentonite, Carbomer, Glyceral
Stearate, Isopropyl Myristate,
PEG-12, Potassium Hydroxide,
Potassium Sorbate, Propylene
Glycol, Water.

Questions?
855-543-3784

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MAXIMUM STRENGTH ACNE SPOT TREATMENT  CVS HEALTH
benzoyl peroxide 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-674
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)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-674-0128 g in 1 TUBE; Type 0: Not a Combination Product08/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/15/2018
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(69842-674) , label(69842-674)

Revised: 6/2018
Document Id: 89e25222-8fcb-4a04-a31c-672a1610ffad
Set id: e617eca2-8aa7-41bb-9391-b309aa4a6aab
Version: 1
Effective Time: 20180605
 
CVS