ZO SKIN HEALTH ECZEMA CONTROL- oatmeal lotion

ZO Skin Health Eczema Control by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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 reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

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

Inactive Ingredients

Ascorbic Acid, Benzalkonium Chloride, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cyclopentasiloxane, Dipotassium Glycyrrhizate, Distearyldimonium Chloride, Glycerin, Isopropyl Palmitate, Maltodextrin, Myristoyl Pentapeptide-11, Ophiopogon Japonicus Root Extract, Petrolatum, Polymethyl Methacrylate, Retinyl Palmitate, Sodium Chloride, Tetrapeptide-21, Tocopheryl Acetate, Water.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-086-04

ECZEMA CONTROL
Skin Protectant Crème

CLINICALLY PROVEN

Net Wt. 113 g / 4 Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH ECZEMA CONTROL 
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-086
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 g

Inactive Ingredients
Ingredient Name	Strength
Ascorbic Acid (UNII: PQ6CK8PD0R)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Benzyl Alcohol (UNII: LKG8494WBH)
Butylene Glycol (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
Cetyl Alcohol (UNII: 936JST6JCN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Distearyldimonium Chloride (UNII: OM9573ZX3X)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Maltodextrin (UNII: 7CVR7L4A2D)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
Petrolatum (UNII: 4T6H12BN9U)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Sodium Chloride (UNII: 451W47IQ8X)
Tetrapeptide-21 (UNII: 179JUC43HU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-086-04	1 in 1 CARTON	05/15/2018
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
OTC monograph final	part347	05/15/2018

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(42851-086)