Indications and uses
For the treatment of acne.
AKNETROL Acne Treatment
- Manufacturer
- ZO Skin Health, Inc. | PhytogenX, Inc.
- Effective date
- 2017-06-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:15:55
Label at a glance#
ProductAKNETROL Acne Treatment
Active ingredientBenzoyl Peroxide
Label structure10 sections
Dosage and administration
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...
Storage and handling
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
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Benzoyl Peroxide 10%
Purpose
Acne Medication
Uses
For the treatment of acne.
Warnings
For external use only.
OTC - DO NOT USE SECTION
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.
OTC - STOP USE SECTION
Stop and ask a doctor if irritation becomes severe.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
SPL UNCLASSIFIED SECTION
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.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42851-070-06 | 2023-03-28 | C162847 | 48780-1 | 9d75b9d0-aeaf-f424-e053-dadaa90a57ce | AKNETROL™ Acne Treatment |
| 42851-070-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-aeaf-f424-e053-dadaa90a57ce | AKNETROL™ Acne Treatment |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzoyl Peroxide | ACTIVE INGREDIENT | W9WZN9A0GM | 1 | |
| Benzoyl Peroxide | ACTIVE MOIETY | W9WZN9A0GM | 1 | |
| Aspalathus Linearis Leaf | INACTIVE INGREDIENT | H7UGK1GJCU | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Green Tea Leaf | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Pinus Strobus Bark | INACTIVE INGREDIENT | 8PJ4761097 | 1 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Sodium Carbonate | INACTIVE INGREDIENT | 45P3261C7T | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| Tea Tree Oil | INACTIVE INGREDIENT | VIF565UC2G | 1 | |
| Vitis Vinifera Seed | INACTIVE INGREDIENT | C34U15ICXA | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- AKNETROL Acne Treatment
- Benzoyl Peroxide
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42851-070 | 42851-070-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / TOPICAL | 3.1 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SOFT TISSUE | 26 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRABURSAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.8 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET / ORAL | 231 mg | ||
| Sodium Carbonate | SODIUM CARBONATE | 45P3261C7T | CAPSULE, EXTENDED RELEASE / ORAL | 6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASPINAL | ADJ PH | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAOCULAR | ADJ PH | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOAP / TOPICAL | 1.26 %w/w | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, EXTENDED RELEASE / ORAL | 17 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 136.55 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / RECTAL | NA | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / IONTOPHORESIS | 0.6 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRATUMOR | ADJ PH | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRADERMAL | 7 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAPERITONEAL | ADJ PH | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPRAY, METERED / NASAL | 320 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL | ADJ PH | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / NASAL | 330 mg | ||
| Sodium Carbonate | SODIUM CARBONATE | 45P3261C7T | GUM, CHEWING / ORAL | 240 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAMUSCULAR | 26 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / VAGINAL | 30 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAUDAL | ADJ PH | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 45 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SWAB / TOPICAL | 5250 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRA-ARTERIAL | 278 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RESPIRATORY (INHALATION) | 108 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| Sodium Hydroxide | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f7fd95e1-7f52-5cfc-e053-6394a90a382d | 79ea7303-6f3f-44ca-8833-c61a49f654c1 | 2023-03-28 | Warnings | 79ea7303-6f3f-44ca-8833-c61a49f654c1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.