REVITATROL EPIDERMAL REPAIR SKIN PROTECTANT- oatmeal lotion

REVITATROL Epidermal Repair Skin Protectant by

Drug Labeling and Warnings

REVITATROL Epidermal Repair 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, 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 - 113 g Tube Carton

ZO®MEDICAL
BY ZEIN OBAGI MD

NDC: 42851-083-12

REVITATROL™
Epidermal Repair Crème
Skin Protectant

Net Wt. 113 g / 4.0 Oz.

INGREDIENTS AND APPEARANCE

REVITATROL EPIDERMAL REPAIR SKIN PROTECTANT 
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	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)
CURDLAN (UNII: 6930DL209R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
DIBENZYL ETHER (UNII: 2O6CNO27RJ)
TETRAPEPTIDE-21 (UNII: 179JUC43HU)
MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-083-12	1 in 1 CARTON	02/17/2016
1		113 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42851-083-56	1 in 1 CARTON	02/01/2016
2		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	02/01/2016

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PAKLAB		790530976	MANUFACTURE(42851-083)