ZO MEDICAL 3-STEP PEEL KIT- oatmeal kit

ZO MEDICAL 3-STEP PEEL Kit by

Drug Labeling and Warnings

ZO MEDICAL 3-STEP PEEL Kit by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., G.S. COSMECEUTICAL USA, INC., PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Keep out of the reach of children

Directions

apply as needed

Inactive ingredients

Water, Glycerin, Petrolatum, Distearyldimonium Chloride, Isopropyl Palmitate, Cyclopentasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Polymethyl Methacrylate, Dipotassium Glycyrrhizate, Benzalkonium Chloride, Butylene Glycol, Tocopheryl Acetate, Pentylene Glycol, 1,2-Hexanediol, Sodium Chloride, Alcohol, Isopropyl Alcohol, Beta-Glucan, Retinyl Palmitate, Ascorbic Acid, Dibenzyl Ether, Tetrapeptide-21, Myristoyl Pentapeptide-11.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO®MEDICAL

BY ZEIN OBAGI MD

NDC: 42851-190-56

ZO® 3-STEP PEEL™
KIT

FOR PROFESSIONAL USE ONLY

6 treatments

INGREDIENTS AND APPEARANCE

ZO MEDICAL 3-STEP PEEL KIT 
oatmeal kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-190

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-190-56	1 in 1 CARTON	12/01/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 BOTTLE, DISPENSING	48 mL
Part 2	12 PACKET	30 g
Part 3	6 TUBE	348 mL

Part 1 of 3

ZO MEDICAL PEEL 
cleansing (cold creams, cleansing lotions, liquids, and pads) solution

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Alcohol (UNII: 3K9958V90M)
INGR	Salicylic Acid (UNII: O414PZ4LPZ)
INGR	Trichloroacetic Acid (UNII: 5V2JDO056X)
INGR	Water (UNII: 059QF0KO0R)
INGR	LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
INGR	Denatonium Benzoate (UNII: 4YK5Z54AT2)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		12/01/2016

Part 2 of 3

ZO MEDICAL RETINOL CREME COMPLEX 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Retinol (UNII: G2SH0XKK91)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	ALLYL METHACRYLATE (UNII: G2IG50653Z)
INGR	Stearyl Alcohol (UNII: 2KR89I4H1Y)
INGR	Polysorbate 60 (UNII: CAL22UVI4M)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	Palmitic Acid (UNII: 2V16EO95H1)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	Hydrogenated Jojoba Oil (UNII: 7F674YQ5SO)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	Ascorbic Acid (UNII: PQ6CK8PD0R)
INGR	Sorbitol (UNII: 506T60A25R)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	HEXAMETHYLCYCLOTRISILOXANE (UNII: EPV75L8O0R)
INGR	CYCLOMETHICONE 4 (UNII: CZ227117JE)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SAFFLOWER OIL (UNII: 65UEH262IS)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
INGR	DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
INGR	APPLE FRUIT OIL (UNII: 9NT987I3A8)
INGR	Myristic Acid (UNII: 0I3V7S25AW)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2.5 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
COSMETIC		12/01/2016

Part 3 of 3

REVITATROL EPIDERMAL REPAIR SKIN PROTECTANT 
oatmeal lotion

Product Information
Item Code (Source)	NDC: 42851-083
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)
Glycerin (UNII: PDC6A3C0OX)
Petrolatum (UNII: 4T6H12BN9U)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Cetyl Alcohol (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
Benzyl Alcohol (UNII: LKG8494WBH)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Butylene Glycol (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Pentylene Glycol (UNII: 50C1307PZG)
1,2-Hexanediol (UNII: TR046Y3K1G)
Sodium Chloride (UNII: 451W47IQ8X)
Alcohol (UNII: 3K9958V90M)
Isopropyl Alcohol (UNII: ND2M416302)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Dibenzyl Ether (UNII: 2O6CNO27RJ)
Tetrapeptide-21 (UNII: 179JUC43HU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-083-56	58 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	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2016

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(42851-190)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(42851-190)