ZO MEDICAL

Manufacturer
ZO Skin Health, Inc. | PakLab | Colonial Enterprises, Inc.
Effective date
2015-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:31

Label at a glance#

ProductZO MEDICAL ZO POST PROCEDURE RECOVERY SYSTEM
Active ingredientALUMINUM ACETATE, OATMEAL
Label structure21 sections

Indications and uses

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

Dosage and administration

Use for the first four days post-procedure. After gently cleansing affected area and/or after applying Surfatrol™, an astringent solution compress, apply a thin coat of ointment and gently massage onto skin to protect and keep out airborne dirt and debris. This helps suppress dryness and scabbing. Applying too much ointment can cause premature skin peeling and increase the likelihood of post-procedure acne. Can al...

Storage and handling

Store at a comfortable temperature range indoors, usually considered to be 68 to 77°F (20 to 25°C). Avoid storing at extreme temperatures above 104°F (40°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

POMATROL™ Soothing Ointment
50 mL / 1.7 Fl. Oz.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Use for the first four days post-procedure. After gently cleansing affected area and/or after applying Surfatrol™, an astringent solution compress, apply a thin coat of ointment and gently massage onto skin to protect and keep out airborne dirt and debris. This helps suppress dryness and scabbing. Applying too much ointment can cause premature skin peeling and increase the likelihood of post-procedure acne. Can also be used whenever skin feels dry or uncomfortable.

CAUTION

WARNINGS SECTION

For external use only. Use only as directed. Keep out of eyes. If contact occurs, rinse thoroughly with cool water. Keep out of reach of children. If rash or other adverse reaction occurs, discontinue use and contact your doctor.

INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Hydrogenated Polyisobutene, Caprylic/Capric/Myristic/Stearic Triglyceride, Glycerin, PEG-15/Lauryl Dimethicone Crosspolymer, Tribehenin, Helianthus Annuus Seed Oil, Beta-Glucan, Polyglyceryl-4 Isostearate, Polyglyceryl-4 Isostearate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Triethylhexanoin, Triethylhexanoin, Polymethyl Methacrylate, Phenoxyethanol, Magnesium Sulfate, Hexyl Laurate, Brassica Oleracea Italica Extract, Avena Sativa Kernel Flour, Panthenyl Triacetate, Ethyl Linoleate, Parfum, Ubiquinone, Erythritol, Chlorphenesin, C12-15 Alkyl Benzoate, Oleyl Alcohol, Sodium Hyaluronate, Tocopheryl Acetate, Butylene Glycol, Acetyl Tyrosine, Aminopropyl Dihydrogen Phosphate, Tocopherol, Proline, Retinyl Palmitate, Ascorbic Acid, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Disodium Acetyl Glucosamine Phosphate, Sodium Benzoate, Sodium Benzoate, Potassium Sorbate, Homarine HCL.

SPL UNCLASSIFIED SECTION

SURFATROL™ Astringent Solution Powder
10 ea. Net Wt. 6 g / 0.21 Oz. (NDC 42851-081-19)

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
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 the 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:

  • dip clean gauze in the solution
  • apply gauze loosely to affected area for 1 to 2 minutes
  • repeat 3-4 times a day as needed or as directed by a doctor
  • discard solution after each use

Other information

STORAGE AND HANDLING SECTION

  • Store at a comfortable temperature range indoors, usually considered to be 68 to 77°F (20 to 25°C).
  • Avoid storing at extreme temperatures above 104°F (40°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

REGENACELL™ Epidermal Repair Crème
Skin Protectant
2 ea. 120 mL / 4.0 Fl. Oz. (NDC 42851-080-12)

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal, 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

  • rashes.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Isostearate, Glycerin, Petrolatum, Dimethicone, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Beta-Glucan, PEG-100 Stearate, Glyceryl Stearate, Steareth-21, Polymethyl Methacrylate, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzalkonium Chloride, Aminomethyl Propanol, Butylene Glycol, Myristoyl Pentapeptide-11, Tocopheryl Acetate, Tetrapeptide-21, Retinyl Palmitate, Ascorbic Acid.

OTHER INFORMATION (STORAGE RECOMMENDATIONS)

STORAGE AND HANDLING SECTION

Store at controlled room temperature: 15-30°C (59-89°F), away from direct sunlight.

SPL UNCLASSIFIED SECTION

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO®MEDICAL
BY ZEIN OBAGI, MD

NDC 42851-082-13

ZO® POST PROCEDURE
RECOVERY SYSTEM

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

FDA-Initiated Inactive NDC Indexing#

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
42851-08242851-082-13
42851-08142851-081-19
42851-08042851-080-12

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 64 matching rows.

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
00eea364-8d6f-7ec1-e063-6294a90aba426450e110-c61f-4a50-aafa-df5c6427c3512023-07-20WarningsExact identifier
spl set id: 6450e110-c61f-4a50-aafa-df5c6427c351

Reported adverse events (FAERS/openFDA)#

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