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ZO MEDICAL ZO POST PROCEDURE RECOVERY SYSTEM

Medically reviewed on May 1, 2018

Dosage form: kit
Ingredients: ; ALUMINUM ACETATE 4866mg in 4.866g; OATMEAL 10mg in 1mL
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-082

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ZO® MEDICAL
ZO® POST PROCEDURE RECOVERY SYSTEM

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

DIRECTIONS

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

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

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.

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

Drug Facts

Active ingredientsPurpose
When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions
Aluminum Sulfate Tetradecahydrate, 2850 mgAstringent
Calcium Acetate Monohydrate, 2016 mgAstringent*

Uses

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

Warnings

For external use only

When using this product
  • 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
  • condition worsens or symptoms persist for more than 7 days

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • 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
  • 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

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

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

Drug Facts

Active ingredient

Colloidal Oatmeal, 1%

Purpose

Skin Protectant

Uses

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

  • rashes.

Warnings

For external use only

When using this product
  • do not get into eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Directions

apply as needed

Inactive ingredients

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)

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

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO®MEDICAL
BY ZEIN OBAGI, MD

NDC 42851-082-13

ZO® POST PROCEDURE
RECOVERY SYSTEM

Established Pharmacological Class
SubstancePharmacological Class
ZO MEDICAL POMATROLCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
ZO MEDICAL  ZO POST PROCEDURE RECOVERY SYSTEM
aluminum sulfate tetradecahydrate, calcium acetate monohydrate, and oatmeal kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-082
Packaging
#Item CodePackage Description
1NDC:42851-082-131 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 50 mL
Part 21 PACKET 6 g
Part 31 TUBE 120 mL
Part 1 of 3
ZO MEDICAL POMATROL 
ointment
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
HYDROGENATED POLYBUTENE (1300 MW) 
GLYCERIN 
TRIBEHENIN 
SUNFLOWER OIL 
CURDLAN 
POLYGLYCERYL-4 ISOSTEARATE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) 
TRIETHYLHEXANOIN 
POLY(METHYL METHACRYLATE; 450000 MW) 
PHENOXYETHANOL 
MAGNESIUM SULFATE 
HEXYL LAURATE 
OATMEAL 
PANTHENOL TRIACETATE, (+)- 
ETHYL LINOLEATE 
SULFURYL FLUORIDE 
UBIDECARENONE 
ERYTHRITOL 
CHLORPHENESIN 
ALKYL (C12-15) BENZOATE 
OLEYL ALCOHOL 
HYALURONATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
BUTYLENE GLYCOL 
N-ACETYLTYROSINE 
AMINOPROPYL DIHYDROGEN PHOSPHATE 
TOCOPHEROL 
PROLINE 
VITAMIN A PALMITATE 
ASCORBIC ACID 
ADENOSINE TRIPHOSPHATE 
SODIUM BENZOATE 
POTASSIUM SORBATE 
HOMARINE HYDROCHLORIDE 
Packaging
#Item CodePackage Description
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC11/14/2014
Part 2 of 3
ZO MEDICAL SURFATROL 
aluminum sulfate tetradecahydrate and calcium acetate monohydrate powder
Product Information
Item Code (Source)NDC:42851-081
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM ACETATE (ALUMINUM CATION) ALUMINUM ACETATE4866 mg  in 4.866 g
Inactive Ingredients
Ingredient NameStrength
ICODEXTRIN 
SOY PROTEIN 
WHEY 
SHRIMP SHELL CHITIN 
POTASSIUM SORBATE 
Packaging
#Item CodePackage Description
1NDC:42851-081-196 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/14/2014
Part 3 of 3
ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT 
oatmeal lotion
Product Information
Item Code (Source)NDC:42851-080
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ISOSTEARATE 
GLYCERIN 
PETROLATUM 
DIMETHICONE 
CETYL ALCOHOL 
SHEANUT OIL 
CURDLAN 
PEG-100 STEARATE 
GLYCERYL MONOSTEARATE 
STEARETH-21 
POLY(METHYL METHACRYLATE; 450000 MW) 
BENZYL ALCOHOL 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
BENZALKONIUM CHLORIDE 
AMINOMETHYLPROPANOL 
BUTYLENE GLYCOL 
MYRISTOYL PENTAPEPTIDE-4 
.ALPHA.-TOCOPHEROL ACETATE 
TETRAPEPTIDE-21 
VITAMIN A PALMITATE 
ASCORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:42851-080-12120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/14/2014
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
PakLab790530976MANUFACTURE(42851-082)
Establishment
NameAddressID/FEIOperations
Colonial Enterprises, Inc.800856333MANUFACTURE(42851-082)

 
ZO Skin Health, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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