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AKNETROL Acne Treatment

Medically reviewed on Jun 5, 2017

Dosage form: lotion
Ingredients: Benzoyl Peroxide 100mg in 1mL
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-070

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.

AKNETROL™ Acne Treatment

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

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 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-070
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:42851-070-061 TUBE in 1 CARTON
160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/2012
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
PhytogenX, Inc.624386772MANUFACTURE(42851-070)

 
ZO Skin Health, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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