Zo Skin Health Skin Normalizing System With Rozatrol Booster Serum
FDA Label NDC 42851-186

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zo Skin Health, Inc. for the product Zo Skin Health Skin Normalizing System With Rozatrol Booster Serum (NDC 42851-186). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by ZO Skin Health, Inc.
5 Technology Dr. Irvine, CA 92618 | 910700

Active Ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

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

Warnings

Flammable. Keep away from heat and open flame.

For external use only.

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

  • If skin irritation occurs or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

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.

Other Information

  • Read the directions and warnings before use.
  • Store at 15–30°C (59–89°F), away from direct sunlight.

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.

Principal Display Panel - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

SKIN NORMALIZING SYSTEM
WITH ROZATROL® BOOSTER SERUM

NDC 42851-186-60

DELIVERED BY

hydrafacial©

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

* Please review the disclaimer below.