ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT- oatmeal lotion

ZO MEDICAL REGENACELL Epidermal Repair Creme Skin Protectant by

Drug Labeling and Warnings

ZO MEDICAL REGENACELL Epidermal Repair Creme Skin Protectant 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 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, 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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 120 mL Tube Label

ZO®MEDICAL
BY ZEIN OBAGI, MD

NDC: 42851-080-12

REGENACELL™
Epidermal Repair Crème

Skin Protectant

120 mL / 4.0 Fl.Oz.

INGREDIENTS AND APPEARANCE

ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT 
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	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	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(42851-080)