Indications and uses
For the management of acne. Penetrates pores to control acne blemishes.
Salicylic Acid
- Manufacturer
- ZO Skin Health, Inc.
- Effective date
- 2023-05-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:31:34
Label at a glance#
ProductZO Skin Health Skin Normalizing System Therapeutic Treatment for red, sensitized skin
Active ingredientSALICYLIC ACID
Label structure10 sections
Dosage and administration
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.
Storage and handling
Read the directions and warnings before use. Store at 15–30°C (59–89°F), away from direct sunlight.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
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 SECTION
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.
SPL UNCLASSIFIED SECTION
Dist. by ZO Skin Health, Inc. Irvine, CA 92618
PRINCIPAL DISPLAY PANEL - Kit Carton
ZO
® SKIN HEALTH
BY
ZEIN OBAGI MD
SKIN NORMALIZING SYSTEM
Therapeutic treatment for red, sensitized skin
NDC 42851-111-60
GENTLE CLEANSER 60 mL / 2 Fl. Oz.
EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
OIL CONTROL PADS 60 Pads
DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
ROZATROL
® 20 mL / 0.67 Fl. Oz.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42851-111-60 | 2023-05-08 | C162847 | 48780-1 | c7ccaba7-1b8a-fd44-e053-dadaa90aa01b | ZO ® Skin Health Skin Normalizing System Therapeutic Treatment for red, sensitized skin National Drug Code 42851-111-60 |
| 42851-111-60 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1b8a-fd44-e053-dadaa90aa01b | ZO ® Skin Health Skin Normalizing System Therapeutic Treatment for red, sensitized skin National Drug Code 42851-111-60 |
Products#
Every source-derived product name is available through these pages.
- ZO Skin Health Skin Normalizing System Therapeutic Treatment for red, sensitized skin
- Salicylic Acid
- ZO Skin Health Gentle Cleanser
- BENZOIC ACID
- D&C RED NO. 33
- FD&C BLUE NO. 1
- EDETATE SODIUM
- WATER
- SODIUM LAURETH-3 SULFATE
- COCAMIDOPROPYL BETAINE
- SODIUM LAUROYL OAT AMINO ACIDS
- GLYCERIN
- PTEROCARPUS SOYAUXII WOOD
- PHELLODENDRON AMURENSE BARK
- BARLEY
- GREEN TEA LEAF
- PLANTAGO LANCEOLATA LEAF
- CRITHMUM MARITIMUM
- LIMONENE, (+)-
- LINALOOL, (+/-)-
- SODIUM CHLORIDE
- BUTYLENE GLYCOL
- ETHYLHEXYLGLYCERIN
- PHENOXYETHANOL
- .ALPHA.-HEXYLCINNAMALDEHYDE
- .BETA.-CITRONELLOL, (R)-
- ZO Skin Health Exfoliating Polish
- POLYETHYLENE GLYCOL 400
- SODIUM BICARBONATE
- MAGNESIUM OXIDE
- DIETHYLENE GLYCOL MONOETHYL ETHER
- OLETH-20
- TRIHYDROXYSTEARIN
- GLYCERYL MONOSTEARATE
- PEG-100 STEARATE
- MINERAL OIL
- .ALPHA.-TOCOPHEROL ACETATE
- TEA TREE OIL
- SOY STEROL
- ASCORBYL PALMITATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42851-111 | 42851-111-60 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| 28df3a92-bb16-e1e1-e063-6394a90a6298 | 3009fce8-9134-4cda-be25-4a1f8480f9ef | 2024-12-09 | Warnings | 3009fce8-9134-4cda-be25-4a1f8480f9ef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.