Label: ACNE WIPEOUT CLINICAL ACNE SYSTEM- benzoyl peroxide kit

  • Category: HUMAN OTC DRUG LABEL

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 October 15, 2020

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  • ACNE WIPEOUT ALL DAY BREAKOUT CONTROL

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 5% w/v

  • Purpose

    Acne treatment

  • Use

    • For the treatment of acne

  • Warnings

    For external use only.

    Do not use • If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. Ask a doctor or pharmacist before use • If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.
    When using this product • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. • Avoid unnecessary sun exposure and use a sunscreen. • Avoid product contact with hair and dyed fabrics, including towels, carpets and clothing which may be bleached by this product.

    Stop use and ask a doctor if
    • if excessive irritation occurs.

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

  • Directions

    Adults and children 12 years of age and older:
    Use every morning after cleansing with Acne Wipeout™ Clear Pore Oil-Free Cleanser. Apply a dime-size amount to clean skin, avoiding the eye area. Do not rinse. If bothersome dryness or irritation occurs, reduce frequency of use.

  • Other information

    • store at room temperature (68° to 77° F)
    • Protect from freezing

  • Inactive Ingredients

    Water (Aqua), Sodium C14-16 Olefin Sulfonate, PEG-8, Disodium Laureth Sulfosuccinate, Polyacrylate-1 Crosspolymer, Cocamidopropyl Betaine, Allyl Methacrylates Crosspolymer, Butylene Glycol, Glycerin, DMDM Hydantoin, Tocopheryl Acetate (Vitamin E Acetate), Glycyrrhiza Glabra (Licorice) Root Extract, Calendula Officinalis Flower Extract, Hamamelis Virginiana (Witch Hazel) Extract, Citric Acid, Tetrasodium EDTA, Sodium Hydroxide, Fragrance, Sodium Benzotriazolyl Butylphenol Sulfonate, Benzoic Acid.

  • QUESTIONS

    Questions? Call toll free 855-299-8800

  • ACNE WIPEOUT CLEAR PORE OIL-FREE CLEANSER

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 2.5% w/v

  • Purpose

    Acne treatment

  • Use

    • For the treatment of acne

  • Warnings

    For external use only.

    Do not use • If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. Ask a doctor or pharmacist before use • If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

    When using this product • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. • Avoid unnecessary sun exposure and use a sunscreen. • Avoid product contact with hair and dyed fabrics, including towels, carpets and clothing which may be bleached by this product.

    Stop use and ask a doctor if
    • excessive irritation occurs.

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

  • Directions

    Adults and children 12 years of age and older:
    Use every morning and evening. Apply to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome dryness or irritation occurs, reduce frequency of use.

  • Other information

    • store at room temperature (68° to 77° F)
    • Protect from freezing
  • Inactive Ingredients

    Carbomer, Ethylhexylglycerin, Jojoba Esters, Phenoxyethanol, Sodium Hydroxide, Water, Silica, Sodium Dioctyl Sulfosuccinate, Xanthan Gum, 1,3 Propanediol, Dimethicone, PEG-40 Stearate.

  • QUESTIONS

    Questions? Call toll free 855-299-8800

  • ACNE WIPEOUT TIME-RELEASED RETINOL PLUS NIGHT CREAM

  • Warnings

    For external use only.

    Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

    Sunburn Alert

    Use a sunscreen, wear protective clothing and limit sun exposure while using this product.

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

  • Directions

    Use only at night. Apply to face after cleansing with Acne Wipeout™ Clear Pore Oil-Free Cleanser. Do not rinse. Limit sun exposure, and use sunscreen when going outdoors. Formulated to minimize irritation. If any irritation occurs, reduce frequency of use. 

  • Ingredients

    Caprylic/Capric Triglyeride, Glycerin, Silica, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Glyceryl Stearate, Retinol, Ceramide-3, Chlorhexidine Gluconate, polysorbate 20, Laureth-23, Cetyl Palmitate, Tridecth-6 Phosphate, Pentylene Glycol, Dimethicone, Ceteareth-20, Carbomer, Sodium Hydroxide, PPG-12 SMDI Copolymer, PEG-100 Stearate, Phenoxyethanol, Disodium EDTA, Ethylhexylglycerin

  • QUESTIONS

    Questions? call toll free 855-299-8800

  • SPL UNCLASSIFIED SECTION

    DERMATOLOGICAL FIRST LINE ACNE CARE

    HIGH SPEED CLEARING

    RESULT START IN 1 HOUR MINIMIZES DRYNESS AND IRRITATION

    24/7 TIME-RELEASED RETINOID + BENZOYL PEROXIDE COMBINATION THERAPY

    ALL DAY BREAKOUT CONTROL 2 FL OZ (60ML)

    CLEAR PORE OIL-FREE CLEANSER 4 FL OZ (120 ML)

    TIME RELEASED RETINOL+ 1 FL OZ (30ML)

    AMERICAN ACADEMY OF DERMATOLOGY FIRST LINE ACNE MEDICATIONS TOPICAL RETINOID + BENZOYL PEROXIDE

    ANTI-INFLAMMATORY

    ANTIBACTERIAL

    NON-COMEDOGENIC

    COMPARE TO PROACTIV MD®

    COMBINATION THERAPY

    Our topical retinoid and benzoyl peroxide work together day and night to target both inflammatory and comedonal acne quickly and effectively. So you can get clear faster.

    TIME-RELEASED
    Minimizes irritation and speeds up results with time-released actives.

    DAY

    All Day Breakout Control delivers time-released benzoyl peroxide into pores to kill acne bacteria on contact, and all day.

    NIGHT

    A natural alternative to Adapalene, Time-Released Retinol+ works all night to unclog pores, essential for benzoyl peroxide to work effectively.

    TIME-RELEASED

    All Day Breakout Control delivers micronized, time-released benzoyl peroxide into pores to kill acne bacteria all day long—while hydrating skin and minimizing irritation and dryness.

    GENTLE EXFOLIATING

    Gently clears pores to deliver medication as you clean, controls shine, calms redness and leaves skin feeling soft and smooth.

    NATURAL RETINOID ALTERNATIVE TO ADAPALENE

    Retinol+ is a natural retinoid enhanced for increased speed and effectiveness, plus time-released to minimize dryness and irritation.

    acnewipeout.com

    made in usa

    UNIVERSITY MEDICAL

    PHARMACEUTICALS CORP

    9671 Irvine Center Drive

    Irvine, CA 92618 ©2020​

    Proactiv is a registered trademark of Guthy-Renker Galderma.

  • Packaging

    ACNE3

    ACNE4

  • INGREDIENTS AND APPEARANCE
    ACNE WIPEOUT CLINICAL ACNE SYSTEM 
    benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-150
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50544-150-441 in 1 KIT; Type 0: Not a Combination Product06/01/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 60 mL
    Part 21 TUBE 120 mL
    Part 31 TUBE 30 mL
    Part 1 of 3
    ACNE WIPEOUT ALL DAY BREAKOUT CONTROL 
    benzoyl peroxide cream
    Product Information
    Item Code (Source)NDC:50544-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: B9J55EA6QX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2020
    Part 2 of 3
    ACNE WIPEOUT CLEAR PORE OIL-FREE CLEANSER 
    benzoyl peroxide gel
    Product Information
    Item Code (Source)NDC:50544-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2020
    Part 3 of 3
    ACNE WIPEOUT TIME-RELEASED RETINOL PLUS NIGHT CREAM 
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRCERAMIDE NP (UNII: 4370DF050B)  
    INGRCHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRLAURETH-23 (UNII: N72LMW566G)  
    INGRCETYL PALMITATE (UNII: 5ZA2S6B08X)  
    INGRTRIDECETH-6 PHOSPHATE (UNII: NKT96BX1OC)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRPPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2020
    Labeler - University Medical Pharmaceuticals Corp. (809706252)