Label: ACNE WIPEOUT CLINICAL ACNE SYSTEM- benzoyl peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 50544-150-44 - Packager: University Medical Pharmaceuticals Corp.
- 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 October 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACNE WIPEOUT ALL DAY BREAKOUT CONTROL
- Active ingredient
- Purpose
- Use
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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. - Directions
- Other information
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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
- ACNE WIPEOUT CLEAR PORE OIL-FREE CLEANSER
- Active ingredient
- Purpose
- Use
-
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. - Directions
- Other information
- Inactive Ingredients
- QUESTIONS
- ACNE WIPEOUT TIME-RELEASED RETINOL PLUS NIGHT CREAM
- Warnings
- Directions
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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
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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
-
INGREDIENTS AND APPEARANCE
ACNE WIPEOUT CLINICAL ACNE SYSTEM
benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50544-150 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50544-150-44 1 in 1 KIT; Type 0: Not a Combination Product 06/01/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 60 mL Part 2 1 TUBE 120 mL Part 3 1 TUBE 30 mL Part 1 of 3 ACNE WIPEOUT ALL DAY BREAKOUT CONTROL
benzoyl peroxide creamProduct Information Item Code (Source) NDC:50544-152 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/01/2020 Part 2 of 3 ACNE WIPEOUT CLEAR PORE OIL-FREE CLEANSER
benzoyl peroxide gelProduct Information Item Code (Source) NDC:50544-151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 120 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/01/2020 Part 3 of 3 ACNE WIPEOUT TIME-RELEASED RETINOL PLUS NIGHT CREAM
face and neck (excluding shaving preparations)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR RETINOL (UNII: G2SH0XKK91) INGR CERAMIDE NP (UNII: 4370DF050B) INGR CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR LAURETH-23 (UNII: N72LMW566G) INGR CETYL PALMITATE (UNII: 5ZA2S6B08X) INGR TRIDECETH-6 PHOSPHATE (UNII: NKT96BX1OC) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/01/2020 Labeler - University Medical Pharmaceuticals Corp. (809706252)