ZO SKIN HEALTH POST PROCEDURE PROGRAM- aluminum acetate kit

ZO Skin Health Post Procedure Program by

Drug Labeling and Warnings

ZO Skin Health Post Procedure Program by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Bentley Laboratories, LLC, LIFETECH RESOURCES LLC, PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

Other Information

• Protect this product from excessive heat and direct sun

Inactive Ingredients

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

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

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH POST PROCEDURE PROGRAM 
aluminum acetate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-187

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-187-06	1 in 1 CARTON	07/02/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	50 mL
Part 2	1 TUBE	113 g
Part 3	1 PACKET	6 g
Part 4	1 TUBE	47 mL
Part 5	1 TUBE	60 mL

Part 1 of 5

ZO SKIN HEALTH SOOTHING OINTMENT 
moisturizing emulsion

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	Triethylhexanoin (UNII: 7K3W1BIU6K)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
INGR	PEG-12 Glyceryl Laurate (UNII: J07WW42G15)
INGR	Broccoli (UNII: UOI4FT57BZ)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
INGR	Tocopherol (UNII: R0ZB2556P8)
INGR	Ascorbic Acid (UNII: PQ6CK8PD0R)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
INGR	Hexyl Laurate (UNII: 4CG9F9W01Q)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
INGR	Ethyl Linoleate (UNII: MJ2YTT4J8M)
INGR	Erythritol (UNII: RA96B954X6)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	9-OCTADECENYL ACETATE, (9Z)- (UNII: EU1ETP025C)
INGR	N-ACETYLTYROSINE (UNII: DA8G610ZO5)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	Proline (UNII: 9DLQ4CIU6V)
INGR	Disodium Acetyl Glucosamine Phosphate (UNII: SC89MF712W)
INGR	Adenosine Triphosphate (UNII: 8L70Q75FXE)
INGR	HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)

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		07/01/2019

Part 2 of 5

ZO SKIN HEALTH HYDRATING CREME 
moisturizing lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
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	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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		113 g 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		07/01/2019

Part 3 of 5

ZO SKIN HEALTH ASTRINGENT SOLUTION 
aluminum acetate powder

Product Information
Item Code (Source)	NDC: 42851-090
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 6 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Oat (UNII: Z6J799EAJK)
Soybean (UNII: L7HT8F1ZOD)
Whey (UNII: 8617Z5FMF6)
Potassium Sorbate (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-090-06	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	07/01/2019

Part 4 of 5

ZO SKIN HEALTH FIRMING SERUM 
moisturizing gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Propanediol (UNII: 5965N8W85T)
INGR	Dipropylene Glycol (UNII: E107L85C40)
INGR	.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
INGR	Vitamin A Palmitate (UNII: 1D1K0N0VVC)
INGR	Caprooyl Tetrapeptide-3 (UNII: LZI0HJ3K2R)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	Hypromellose, Unspecified (UNII: 3NXW29V3WO)
INGR	Carboxypolymethylene (UNII: 0A5MM307FC)
INGR	Aminomethylpropanol (UNII: LU49E6626Q)
INGR	Powdered Cellulose (UNII: SMD1X3XO9M)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Lactose, Unspecified Form (UNII: J2B2A4N98G)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)
INGR	EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
INGR	Limonene, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		47 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		07/01/2019

Part 5 of 5

ZO SKIN HEALTH GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Sodium Lauroyl Oat Amino Acids (UNII: FSW2K9B9N5)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Pterocarpus Soyauxii Wood (UNII: 0V6QB4C61P)
INGR	Phellodendron Amurense Bark (UNII: PBG27B754G)
INGR	Barley (UNII: 5PWM7YLI7R)
INGR	Green Tea Leaf (UNII: W2ZU1RY8B0)
INGR	Plantago Lanceolata Leaf (UNII: 2YWL9J7EE8)
INGR	Crithmum Maritimum (UNII: J7IHY79BKY)
INGR	Limonene, (+)- (UNII: GFD7C86Q1W)
INGR	Linalool, (+/-)- (UNII: D81QY6I88E)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 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		07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	07/02/2019

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	LABEL(42851-187) , MANUFACTURE(42851-187) , PACK(42851-187)

Establishment
Name	Address	ID/FEI	Business Operations
Paramount Cosmetics		001321058	MANUFACTURE(42851-187) , PACK(42851-187)

Establishment
Name	Address	ID/FEI	Business Operations
LIFETECH RESOURCES LLC		081239587	MANUFACTURE(42851-187)