Label: SPOTLESS DAILY ACNE WASH- benzoyl peroxide 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 December 29, 2020

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

  • Active Ingredients

    Benzoyl Peroxide 5%

  • Purpose

    Acne treatment

  • Uses

    For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

  • Warnings

    For external use only

    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.

    Do not use if you

    • Have very sensitive skin.
    • Are sensitive to benzoyl peroxide.

    When using this product

    • 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 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

    • Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes. Rinse thoroughly and pat dry. Use once daily and increase to twice daily as tolerated. Wash hands after application to help avoid staining fabrics
    • 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
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other Information

    Store between 15-30°C (59-86°F). This product may bleach hair or dyed fabrics.

  • Inactive Ingredients

    Water, Polyacrylamide, C13-14 lsoparaffin, Jojoba Esters, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Cocamidopropyl Betaine, Laureth-7, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Sodium Benzoate

  • Questions

    1-888-995-5656

  • Principal Display Panel - 125 mL Carton Label

    RODAN+FIELDS

    SPOTLESS

    DAILY
    ACNE
    WASH

    1

    125 mL/4.2 Fl. Oz. U.S.

    Principal Display Panel - 125 mL Carton Label
  • Principal Display Panel - 125 mL Tube Label

    RODAN+FIELDS

    SPOTLESS

    DAILY
    ACNE
    WASH

    1

    Principal Display Panel - 125 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    SPOTLESS DAILY ACNE WASH 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-1610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-1610-11 in 1 CARTON02/13/2019
    1125 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/13/2019
    Labeler - Rodan & Fields (051659584)