Drug Facts

Active Ingredient	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 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:

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

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

Other Information

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

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

PRINCIPAL DISPLAY PANEL - Kit Carton

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

ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM
aluminum acetate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42851-193

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-193-06	1 in 1 CARTON	01/31/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	50 mL
Part 2	1 TUBE	113 g
Part 3	1 PACKET	6 g

Part 1 of 3

ZO SKIN HEALTH POMATROL SOOTHING
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] ointment

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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	POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
INGR	TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
INGR	HEXYL LAURATE (UNII: 4CG9F9W01Q)
INGR	BROCCOLI (UNII: UOI4FT57BZ)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
INGR	ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
INGR	ERYTHRITOL (UNII: RA96B954X6)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	OLEYL ALCOHOL (UNII: 172F2WN8DV)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	N-ACETYLTYROSINE (UNII: DA8G610ZO5)
INGR	AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)
INGR	PROLINE (UNII: 9DLQ4CIU6V)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)
INGR	DISODIUM ACETYL GLUCOSAMINE PHOSPHATE (UNII: SC89MF712W)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
INGR	PEG-12 GLYCERYL LAURATE (UNII: J07WW42G15)
INGR	HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
INGR	POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/31/2019

Part 2 of 3

ZO SKIN HEALTH HYDRATING CREME
body and hand (excluding shaving preparations), rinse-off [skin care preparations (creams, lotions, powder, and sprays)] lotion

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PETROLATUM (UNII: 4T6H12BN9U)
INGR	DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
INGR	ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	TETRAPEPTIDE-21 (UNII: 179JUC43HU)
INGR	MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/31/2019

Part 3 of 3

ZO SKIN HEALTH SURFATROL ASTRINGENT SOLUTION
aluminum acetate powder

Product Information
Item Code (Source)	NDC:42851-088
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	4866 mg in 6 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
OAT (UNII: Z6J799EAJK)
SOY PROTEIN (UNII: R44IWB3RN5)
WHEY (UNII: 8617Z5FMF6)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-088-06	6 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	01/31/2019

Labeler - ZO Skin Health, Inc. (826468527)

Name	Address	ID/FEI	Business Operations
Establishment
Bentley Laboratories, LLC		068351753	manufacture(42851-193)

ZO ®Skin Health Post Procedure Recovery System