ACNE WIPEOUT CLINICAL ACNE SYSTEM- benzoyl peroxide kit

ACNE WIPEOUT CLINICAL ACNE System by

Drug Labeling and Warnings

ACNE WIPEOUT CLINICAL ACNE System by is a Otc medication manufactured, distributed, or labeled by University Medical Pharmaceuticals Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACNE WIPEOUT CLINICAL ACNE SYSTEM 
benzoyl peroxide kit

Product 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 cream

Product 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 gel

Product 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)