FDA.reportPublic FDA data

ZO Skin Health Post Procedure Recovery System

Manufacturer
ZO Skin Health, Inc. | Bentley Laboratories, LLC
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:49:03

Label at a glance#

ProductZO Skin Health Post Procedure Recovery System
Active ingredientALUMINUM ACETATE
Label structure9 sections

Indications and uses

For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

Dosage and administration

dissolve 1 packet in 12 oz. of cool or warm water. stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.45% aluminum acetate and is ready for use. For use as a compress or wet dressing: soak a clean, soft cloth in the solution apply cloth loosely to affected area for 15 to 30 minutes repeat as needed or as directed by a doctor discard solution after each use

Storage and handling

Store at controlled room temperature: 15-30°C (59-86°F), away from direct sunlight. You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Aluminum Sulfate Tetradecahydrate, 2850 mgAstringent *
Calcium Acetate Monohydrate, 2016 mgAstringent *

* When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • do not cover compress or wet dressing with plastic to prevent evaporation
  • in some skin conditions, soaking too long may overdry

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days

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

DOSAGE & ADMINISTRATION SECTION

  • dissolve 1 packet in 12 oz. of cool or warm water.
  • stir until fully dissolved; do not strain or filter.

The resulting mixture contains 0.45% aluminum acetate and is ready for use.

For use as a compress or wet dressing:

  • soak a clean, soft cloth in the solution
  • apply cloth loosely to affected area for 15 to 30 minutes
  • repeat as needed or as directed by a doctor
  • discard solution after each use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein, Potassium Sorbate, Chitosan.

Other Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature: 15-30°C (59-86°F), away from direct sunlight.
  • You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ®SKIN HEALTH
BY ZEIN OBAGI MD

POST PROCEDURE RECOVERY SYSTEM

NDC 42851-193-06

POMATROL ®Soothing Ointment 50 mL / 1.7 Fl. Oz.
HYDRATING CRÈME Net Wt.113 g / 4 Oz.
SURFATROL ®Astringent Solution Powder 10 ea. Net Wt.6 g / 0.21 Oz.

US Patent No. 9,248,160

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-193-062022-06-30C16284748780-1c7ccaba7-1203-fd44-e053-dadaa90aa01bZO ® Skin Health Post Procedure Recovery System
42851-193-062021-07-23C16284748780-1c7ccaba7-1203-fd44-e053-dadaa90aa01bZO ® Skin Health Post Procedure Recovery System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-088-06ZO Skin Health Post Procedure Recovery System6 g in 1 PACKETPOWDER6 g4866 mg in 6g5
42851-193-06ZO Skin Health Post Procedure Recovery System1 in 1 CARTONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-088ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM (ALUMINUM ACETATE) KIT [ZO SKIN HEALTH, INC.]5Unmatched20241228_3b977415-2bf4-43a9-bb48-1eb023ca4f53.zip
42851-193ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM (ALUMINUM ACETATE) KIT [ZO SKIN HEALTH, INC.]5Current NDC, Legacy NDC, 2 package rows20241228_3b977415-2bf4-43a9-bb48-1eb023ca4f53.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 61 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-19342851-193-06
42851-08842851-088-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 66 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RINGR
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZINGR
GLYCERINPDC6A3C0OXINGR
TRIBEHENIN8OC9U7TQZ0INGR
SUNFLOWER OIL3W1JG795YIINGR
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7INGR
TRIETHYLHEXANOIN7K3W1BIU6KINGR
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11INGR
PHENOXYETHANOLHIE492ZZ3TINGR
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABINGR
HEXYL LAURATE4CG9F9W01QINGR
BROCCOLIUOI4FT57BZINGR
OATMEAL8PI54V663YINGR
PANTHENOL TRIACETATE, (+)-1206E8961BINGR
ETHYL LINOLEATEMJ2YTT4J8MINGR
ERYTHRITOLRA96B954X6INGR
CHLORPHENESINI670DAL4SZINGR
ALKYL (C12-15) BENZOATEA9EJ3J61HQINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
OLEYL ALCOHOL172F2WN8DVINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
N-ACETYLTYROSINEDA8G610ZO5INGR
AMINOPROPYL DIHYDROGEN PHOSPHATED5J0Q2CM4VINGR
PROLINE9DLQ4CIU6VINGR
UBIDECARENONEEJ27X76M46INGR
VITAMIN A PALMITATE1D1K0N0VVCINGR
ASCORBIC ACIDPQ6CK8PD0RINGR
TOCOPHEROLR0ZB2556P8INGR
ADENOSINE TRIPHOSPHATE8L70Q75FXEINGR
DISODIUM ACETYL GLUCOSAMINE PHOSPHATESC89MF712WINGR
HYALURONATE SODIUMYSE9PPT4THINGR
SODIUM BENZOATEOJ245FE5EUINGR
POTASSIUM SORBATE1VPU26JZZ4INGR
POLYOXYL 35 CASTOR OIL6D4M1DAL6OINGR
PEG-12 GLYCERYL LAURATEJ07WW42G15INGR
HOMARINE HYDROCHLORIDE8866LNG61NINGR
POVIDONE, UNSPECIFIEDFZ989GH94EINGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
ndc (package): 42851-193-06
ndc (package): 42851-088-06
ndc (product): 42851-193
ndc11 (package): 42851019306
ndc11 (package): 42851008806
spl id: f0976c84-02c2-4fa3-9933-5f30fc37fca9
spl set id: 3b977415-2bf4-43a9-bb48-1eb023ca4f53

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.