Zo ®

Zo ®
SPL v9
SPL
SPL Set ID 84283a64-8f31-4e98-ad04-948dbe94887d
Route
TOPICAL
Published
Effective Date 2020-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Urea Water Mandelic Acid Phellodendron Amurense Bark Glycolic Acid Tert-butyl Alcohol Denatonium Benzoate Edetate Disodium Anhydrous Green Tea Leaf Butylene Glycol Crithmum Maritimum Sodium Chloride Sodium Carbonate Hamamelis Virginiana Top Menthyl Lactate, (-)- Plantago Lanceolata Leaf Pterocarpus Soyauxii Wood Rosa Canina Fruit Alcohol Phenoxyethanol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Drug Facts

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Drug Facts

Uses
  • For the management of acne.
  • Penetrates pores to control acne blemishes.
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

Flammable. Keep away from heat and open flame.

For external use only.

Directions
  • 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.
Active Ingredient

Salicylic Acid 2.0%

Other Information
  • Protect this product from excessive heat and direct sun
Inactive Ingredients

Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.

Recent Changes Summary

Contents of Labelling Updates

Capitalized the beginning of all sentences in Directions section.

Deleted from Other Information section: “Read the directions and warnings before use.”

Capitalized sub-heading Active Ingredient

Capitalized active ingredient Salicylic Acid 2.0%

Revised Active Ingredient’s Purpose from “Acne treatment” to “Acne Medication”

Capitalized the beginning of all sentences under Uses section.

Bolded “For external use only.”

Corrected “Stop use and ask a doctor if” to “Stop use and ask a doctor”

Artwork

Uploaded unit carton (SKU no. 928300) to replace previous mark-up’s secondary label (SKU no. 925000).

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.
Stop Use and Ask A Doctor
  • if skin irritation occurs or gets worse.
Principal Display Panel 60 Pad Jar Carton

ZO ®SKIN HEALTH



BY ZEIN OBAGI MD

NDC 42851-085-60

OIL CONTROL PADS



ACNE TREATMENT

2% Salicylic Acid

60 Pads


Structured Label Content

Uses
  • For the management of acne.
  • Penetrates pores to control acne blemishes.
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

Flammable. Keep away from heat and open flame.

For external use only.

Directions
  • 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.
Active Ingredient (Active ingredient)

Salicylic Acid 2.0%

Other Information (Other information)
  • Protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.

Recent Changes Summary

Contents of Labelling Updates

Capitalized the beginning of all sentences in Directions section.

Deleted from Other Information section: “Read the directions and warnings before use.”

Capitalized sub-heading Active Ingredient

Capitalized active ingredient Salicylic Acid 2.0%

Revised Active Ingredient’s Purpose from “Acne treatment” to “Acne Medication”

Capitalized the beginning of all sentences under Uses section.

Bolded “For external use only.”

Corrected “Stop use and ask a doctor if” to “Stop use and ask a doctor”

Artwork

Uploaded unit carton (SKU no. 928300) to replace previous mark-up’s secondary label (SKU no. 925000).

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.
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if skin irritation occurs or gets worse.
Principal Display Panel 60 Pad Jar Carton (PRINCIPAL DISPLAY PANEL - 60 Pad Jar Carton)

ZO ®SKIN HEALTH



BY ZEIN OBAGI MD

NDC 42851-085-60

OIL CONTROL PADS



ACNE TREATMENT

2% Salicylic Acid

60 Pads


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)