AKNETROL Acne Treatment description, usages, side effects, indications, overdosage, supplying and lots more!

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AKNETROL Acne Treatment

ZO Skin Health, Inc.

AKNETROL™ Acne Treatment


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

AKNETROL Acne Treatment 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.

AKNETROL Acne Treatment 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

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.

AKNETROL Acne Treatment

AKNETROL Acne Treatment

Benzoyl Peroxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42851-070
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 100 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
propylene glycol
polyethylene glycol 400
GREEN TEA LEAF
PINUS STROBUS BARK
ASPALATHUS LINEARIS LEAF
VITIS VINIFERA SEED
TEA TREE OIL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
EDETATE DISODIUM
SODIUM CARBONATE
SODIUM CHLORIDE
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 TUBE
2 NDC:42851-070-06 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2012-01-01


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Be sure to consult your doctor before taking any medication!
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