Label: SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- benzoyl peroxide kit

  • 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 February 13, 2019

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

  • Active Ingredient

    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 or every other 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 Isoparaffin, 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

  • Acne Clearing Treatment

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 2.5%

  • 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

    • 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 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

    • Clean the skin thoroughly before applying this product.
    • Dispense 1-2 pumps and cover the entire affected area with a thin even layer one to three times daily. Do not rinse product off face.
    • 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
    • Wash hands after application to help avoid staining fabrics.
  • Other Information

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

  • Inactive Ingredients

    Water, Glycereth-18 Ethylhexanoate, Glycereth-18, Glycerin, Butylene Glycol, Vaccinium Angustifolium (Blueberry) Fruit Extract, Sodium Hyaluronate, Polygonum Cuspidatum Root Extract, Bisabolol, Allantoin, Zingiber Officinale (Ginger) Root Extract, Octenidine HCl, Fragrance, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Methyl Methacrylate Crosspolymer, Myristyl Alcohol, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Cyclopentasiloxane, Butyl Hydroxycyclohexane Carboxylate, Dimethyl Isosorbide, Carbomer, Polyglyceryl-2 Isostearate, Sorbitan Oleate, Diethylhexyl Sodium Sulfosuccinate, Cetyl Hydroxyethylcellulose, Cyclohexasiloxane, Polysorbate 80, Xanthan Gum, Hydroxyphenyl Propamidobenzoic Acid, Ascorbyl Palmitate, Tocopherol, PCA, Sodium Citrate, Citric Acid, Sodium Hydroxide, Propanediol, Pentylene Glycol, Isohexadecane, Caprylyl Glycol, 1,2-Hexanediol, Decylene Glycol, Hydroxyacetophenone, Propylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Citral, Citronellol, Limonene, Linalool, Titanium Dioxide (CI 77891), Mica, Tin Oxide, Blue 1 (CI 42090), Red 33 (CI 17200), Violet 2 (CI 60725)

  • Questions

    1-888-995-5656

  • Principal Display Panel - Kit Label

    RODAN+FIELDS

    SPOTLESS

    REGIMEN FOR
    ACNE, BLEMISHES
    AND BREAKOUTS

    DESIGNED FOR
    TEENS AND YOUNG ADULTS

    Eliminate acne-causing bacteria

    Helps clear blackheads, whiteheads
    and pimples

    Helps prevent new blemishes
    from forming

    Reduces shine

    DEVELOPED BY STANFORD-TRAINED
    DERMATOLOGISTS DR.KATIE RODAN
    AND DR.KATHY FIELDS

    Daily Acne Wash

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

    Acne Clearing Treatment

    50 mL/1.7 Fl. Oz. U.S.

    Principal Display Panel - Kit Label
  • Principal Display Panel - Acne Clearing Treatment Tube Label

    RODAN+FIELDS

    SPOTLESS

    ACNE
    CLEARING
    TREATMENT

    2

    Principal Display Panel - Acne Clearing Treatment Tube Label
  • Principal Display Panel - Daily Acne Wash Tube Label

    RODAN+FIELDS

    SPOTLESS

    DAILY
    ACNE
    WASH

    1

    Principal Display Panel - Daily Acne Wash Tube Label
  • INGREDIENTS AND APPEARANCE
    SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS 
    benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-1600
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-1600-11 in 1 CARTON; Type 1: Convenience Kit of Co-Package02/13/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 125 mL
    Part 21 BOTTLE, PUMP 50 mL
    Part 1 of 2
    SPOTLESS DAILY ACNE WASH 
    benzoyl peroxide cream
    Product Information
    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
    1125 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/13/2019
    Part 2 of 2
    SPOTLESS ACNE CLEARING TREATMENT 
    benzoyl peroxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.025 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)  
    GLYCERETH-18 (UNII: SA5E43C17C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GINGER (UNII: C5529G5JPQ)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    MICA (UNII: V8A1AW0880)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    OCTENIDINE HYDROCHLORIDE (UNII: U84956NU4B)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    PIDOLIC ACID (UNII: SZB83O1W42)  
    POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/13/2019
    Labeler - Rodan & Fields (051659584)