ZO MEDICAL ZO POST PROCEDURE RECOVERY SYSTEM- aluminum sulfate tetradecahydrate, calcium acetate monohydrate, and oatmeal kit

ZO MEDICAL by

Drug Labeling and Warnings

ZO MEDICAL by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., PakLab, Colonial Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

Drug Facts

ACTIVE INGREDIENT

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

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.

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

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ZO MEDICAL  ZO POST PROCEDURE RECOVERY SYSTEM
aluminum sulfate tetradecahydrate, calcium acetate monohydrate, and oatmeal kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-082

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-082-13	1 in 1 CARTON	11/14/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	50 mL
Part 2	1 PACKET	6 g
Part 3	1 TUBE	120 mL

Part 1 of 3

ZO MEDICAL POMATROL 
cleansing (cold creams, cleansing lotions, liquids, and pads) ointment

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	TRIBEHENIN (UNII: 8OC9U7TQZ0)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	CURDLAN (UNII: 6930DL209R)
INGR	POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
INGR	CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
INGR	TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	MAGNESIUM SULFATE (UNII: DE08037SAB)
INGR	HEXYL LAURATE (UNII: 4CG9F9W01Q)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
INGR	ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
INGR	SULFURYL FLUORIDE (UNII: 64B59K7U6Q)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	ERYTHRITOL (UNII: RA96B954X6)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	OLEYL ALCOHOL (UNII: 172F2WN8DV)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	N-ACETYLTYROSINE (UNII: DA8G610ZO5)
INGR	AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	PROLINE (UNII: 9DLQ4CIU6V)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		11/14/2014

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	4866 mg  in 4.866 g

Inactive Ingredients
Ingredient Name	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G)
SOY PROTEIN (UNII: R44IWB3RN5)
WHEY (UNII: 8617Z5FMF6)
SHRIMP SHELL CHITIN (UNII: 8SH93A7QWW)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-081-19	6 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/14/2014

Part 3 of 3

ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT 
oatmeal lotion

Product Information
Item Code (Source)	NDC: 42851-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEANUT OIL (UNII: O88E196QRF)
CURDLAN (UNII: 6930DL209R)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARETH-21 (UNII: 53J3F32P58)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-080-12	120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/14/2014

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(42851-082)

Establishment
Name	Address	ID/FEI	Business Operations
Colonial Enterprises, Inc.		800856333	MANUFACTURE(42851-082)