AKNETROL ACNE TREATMENT- benzoyl peroxide lotion

AKNETROL Acne Treatment by

Drug Labeling and Warnings

AKNETROL Acne Treatment by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

For the treatment of acne.

Warnings

For external use only.

Do not use if you

• have very sensitive skin.
• are sensitive to benzoyl peroxide.

When using this product

• Skin irritation and dryness are 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.
• Avoid unnecessary sun exposure and use a sunscreen.
• Avoid contact with 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 possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first three days of use. If no discomfort occurs, follow the directions stated below:

• Cleanse skin thoroughly before applying Aknetrol™.
• Apply thin layer on affected area twice a day or as directed by a physician. Rub until vanished.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by your doctor.
• If bothersome dryness or peeling occurs, reduce application to once every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of product and consult a physician.

Inactive ingredients

Water, Glycerin, Propylene Glycol, Polyglyceryl-6 Isostearate, PEG-8, Camellia Sinensis Leaf Extract, Pinus Strobus Bark Extract, Aspalathus Linearis Leaf Extract, Vitis Vinifera (Grape) Seed Extract, Carbomer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Ethylhexyglycerin, Disodium EDTA, Sodium Carbonate, Sodium Chloride, Sodium Hydroxide.

Other information

• Protect the product in this container from excessive heat and direct sunlight.
• You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618

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DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

ZO®MEDICAL

BY ZEIN OBAGI, MD

AKNETROL™

Acne Treatment

Benzoyl Peroxide 10%

60 mL / 2 Fl. Oz.

INGREDIENTS AND APPEARANCE

AKNETROL ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Pinus Strobus Bark (UNII: 8PJ4761097)
Aspalathus Linearis Leaf (UNII: H7UGK1GJCU)
Vitis Vinifera Seed (UNII: C34U15ICXA)
Tea Tree Oil (UNII: VIF565UC2G)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Carbonate (UNII: 45P3261C7T)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-070-06	1 in 1 CARTON	01/01/2012
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	01/01/2012

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	MANUFACTURE(42851-070)