FDA.reportPublic FDA data

ZO Skin Health Post Procedure Program

Manufacturer
ZO Skin Health, Inc. | Bentley Laboratories, LLC
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:37:30

Label at a glance#

ProductZO Skin Health Post Procedure Program
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

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

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

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

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 PROGRAM
NDC 42851-187-06

GENTLE CLEANSER 60 mL / 2.0 Fl. Oz
FIRMING SERUM 47 mL / 1.6 Fl. Oz
SOOTHING OINTMENT 50 mL / 1.7 Fl. Oz.
HYDRATING CRÈME Net Wt. 113 g / 4 Oz.
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-187-062022-07-07C16284748780-1c7ccaba7-2af3-fd44-e053-dadaa90aa01bZO ® Skin Health Post Procedure Program
42851-187-062021-07-23C16284748780-1c7ccaba7-2af3-fd44-e053-dadaa90aa01bZO ® Skin Health Post Procedure Program

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-090-06ZO Skin Health Post Procedure Program6 g in 1 PACKETPOWDER6 g4866 mg in 6g5
42851-187-06ZO Skin Health Post Procedure Program1 in 1 CARTONKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-090ZO SKIN HEALTH POST PROCEDURE PROGRAM (ALUMINUM ACETATE) KIT [ZO SKIN HEALTH, INC.]5Current NDC, Legacy NDC20241116_9786acc8-06ae-4f2b-9602-b7e8c3baeca5.zip
42851-187ZO SKIN HEALTH POST PROCEDURE PROGRAM (ALUMINUM ACETATE) KIT [ZO SKIN HEALTH, INC.]5Current NDC, Legacy NDC, 2 package rows20241116_9786acc8-06ae-4f2b-9602-b7e8c3baeca5.zip

Products#

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

DailyMed product names page 1 of 3 · 90 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-18742851-187-06
42851-09042851-090-06

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 107 matching rows.

Name, UNII, Kind table
NameUNIIKind
PANTHENOL TRIACETATE, (+)-1206E8961BINGR
WATER059QF0KO0RINGR
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZINGR
GLYCERINPDC6A3C0OXINGR
TRIBEHENIN8OC9U7TQZ0INGR
TRIETHYLHEXANOIN7K3W1BIU6KINGR
SUNFLOWER OIL3W1JG795YIINGR
POVIDONE, UNSPECIFIEDFZ989GH94EINGR
PEG-12 GLYCERYL LAURATEJ07WW42G15INGR
BROCCOLIUOI4FT57BZINGR
OATMEAL8PI54V663YINGR
POLYOXYL 35 CASTOR OIL6D4M1DAL6OINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABINGR
TOCOPHEROLR0ZB2556P8INGR
ASCORBIC ACIDPQ6CK8PD0RINGR
VITAMIN A PALMITATE1D1K0N0VVCINGR
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7INGR
HEXYL LAURATE4CG9F9W01QINGR
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11INGR
ETHYL LINOLEATEMJ2YTT4J8MINGR
ERYTHRITOLRA96B954X6INGR
ALKYL (C12-15) BENZOATEA9EJ3J61HQINGR
9-OCTADECENYL ACETATE, (9Z)-EU1ETP025CINGR
N-ACETYLTYROSINEDA8G610ZO5INGR
UBIDECARENONEEJ27X76M46INGR
PROLINE9DLQ4CIU6VINGR
DISODIUM ACETYL GLUCOSAMINE PHOSPHATESC89MF712WINGR
ADENOSINE TRIPHOSPHATE8L70Q75FXEINGR
HOMARINE HYDROCHLORIDE8866LNG61NINGR
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
HYALURONATE SODIUMYSE9PPT4THINGR
CHLORPHENESINI670DAL4SZINGR
SODIUM BENZOATEOJ245FE5EUINGR
POTASSIUM SORBATE1VPU26JZZ4INGR
PHENOXYETHANOLHIE492ZZ3TINGR
LIMONENE, (+)-GFD7C86Q1WINGR
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Post Procedure ProgramALUMINUM ACETATEZO Skin Health, Inc.9786acc8-06ae-4f2b-9602-b7e8c3baeca52024-11-12WarningsExact identifier
ndc (package): 42851-187-06
ndc (package): 42851-090-06
ndc (product): 42851-187
ndc11 (package): 42851009006
ndc11 (package): 42851018706
spl id: 26bbbd26-9458-b6e4-e063-6394a90a887d
spl set id: 9786acc8-06ae-4f2b-9602-b7e8c3baeca5
ZO Skin Health Astringent SolutionALUMINUM ACETATEZO Skin Health, Inc.cb801d7e-52ad-6c16-e053-2a95a90a7a1f2024-10-31WarningsExact identifier
ndc (package): 42851-090-06
ndc11 (package): 42851009006

Reported adverse events (FAERS/openFDA)#

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