Label: ACNE FOAMING WASH DAYLODIC- benzoyl peroxide 10% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 14, 2018

If you are a consumer or patient please visit this version.

  • 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 if you 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 occurses, only use one topical acne medicine at the time
    •  rinse rightaway 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 occurs, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a low concentration.
  • Stop use and consult a doctor if

    irritation become severe.

  • Keep out of reach of children

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

  • Directions

    • Wet face
    • Apply to hands and work into a lather
    • Massage face gently
    • Rinse thoroughly and pat dry
    • Clease twice a day
    • If going outside apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and consult a doctor
  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Cocamidopropyl Betaine, Glycerin, Glycolic Acid, Imidazolidinyl Urea, Lactic Acid, Methylparaben, Mineral Oil, Potassium lauryl Sulfate, Purified Water, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium PCA, Titanium Dioxide

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE FOAMING WASH  DAYLODIC
    benzoyl peroxide 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1216
    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
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    IMIDUREA (UNII: M629807ATL)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM LAURYL PHOSPHATE (UNII: C4QT53N4MK)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1216-51 in 1 CARTON09/15/2016
    1156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/15/2016
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(11822-1216) , label(11822-1216)