ACNE WIPEOUT ALL DAY BREAKOUT CONTROL- benzoyl peroxide cream

ACNE WIPEOUT ALL DAY BREAKOUT CONTROL by

Drug Labeling and Warnings

ACNE WIPEOUT ALL DAY BREAKOUT CONTROL by is a Otc medication manufactured, distributed, or labeled by University Medical Pharmaceuticals Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
 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. May be applied all over face to help control future breakouts.

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

SPL UNCLASSIFIED SECTION

DERMATOLOGICAL FIRST LINE ACNE CARE

HYDRATING CREAM

TIME-RELEASED

5% BENZOYL PEROXIDE ACNE TREATMENT

MINIMIZES IRRITATION AND DRYNESS

PART OF THE ACNE WIPEOUT CLINICAL ACNE SYSTEM

acnewipeout.com

made in usa

UNIVERSITY MEDICAL

PHARMACEUTICALS CORP

9671 Irvine Center Drive

Irvine, CA 92618 ©2020

EFFECTIVE CLEARING + HYDRATION ALL DAY LONG

NON-COMEDOGENIC

FRAGRANCE FREE

PARABEN FREE

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.

Packaging

INGREDIENTS AND APPEARANCE

ACNE WIPEOUT ALL DAY BREAKOUT CONTROL 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	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	NDC: 50544-152-00	1 in 1 CARTON	06/01/2020
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

Labeler - University Medical Pharmaceuticals Corp. (809706252)