Zo ®

Zo ®
SPL v6
SPL
SPL Set ID 252b2352-a457-4009-a62b-0ec98f018b2e
Route
TOPICAL
Published
Effective Date 2019-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Aspalathus Linearis Leaf Green Tea Leaf Carbomer Homopolymer, Unspecified Type Docusate Sodium Dimethicone Edetate Disodium Anhydrous Ethylhexylglycerin Glycerin Tea Tree Oil Peg-40 Stearate Peg-8 Laurate Phenoxyethanol Pinus Strobus Bark Polyglyceryl-6 Isostearate Propanediol Propylene Glycol Silicon Dioxide Sodium Citrate, Unspecified Form Sodium Hydroxide Sorbitan Monostearate Vitis Vinifera Seed Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-25

Description

Drug Facts

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Drug Facts

Uses

For the treatment of acne.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.
Warnings

For external use only.

Directions

Sensitivity Test for a New User.

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient

Benzoyl Peroxide 10%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide.
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Aqua/Water/Eau, Aspalathus Linearis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-40 Stearate, PEG-8 Laurate, Phenoxyethanol, Pinus Strobus Bark Extract, Polyglyceryl-6 Isostearate, Propanediol, Propylene Glycol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.

When Using This Product
  • skin irritation and dryness is 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 the 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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use and Ask A Doctor If
  • irritation becomes severe
Principal Display Panel 60 Ml Tube Carton

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-087-60

ACNE CONTROL

10% Benzoyl Peroxide

60 mL / 2 Fl. Oz.


Structured Label Content

Uses

For the treatment of acne.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Acne Medication

Warnings

For external use only.

Directions

Sensitivity Test for a New User.

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient

Benzoyl Peroxide 10%

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide.
Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Aqua/Water/Eau, Aspalathus Linearis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-40 Stearate, PEG-8 Laurate, Phenoxyethanol, Pinus Strobus Bark Extract, Polyglyceryl-6 Isostearate, Propanediol, Propylene Glycol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.

When Using This Product (When using this product)
  • skin irritation and dryness is 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 the 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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation becomes severe
Principal Display Panel 60 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton)

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-087-60

ACNE CONTROL

10% Benzoyl Peroxide

60 mL / 2 Fl. Oz.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)