AKNETROL ACNE TREATMENT- benzoyl peroxide lotion 
ZO Skin Health, Inc.

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.

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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.

Principal Display Panel - 60 mL Tube Carton
AKNETROL ACNE TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-070-061 in 1 CARTON01/01/2012
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/201206/01/2020
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc.624386772manufacture(42851-070)

Revised: 3/2023
 
ZO Skin Health, Inc.