REVITATROL EPIDERMAL REPAIR SKIN PROTECTANT- oatmeal lotion 
ZO Skin Health, Inc.

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REVITATROL™ Epidermal Repair Crème Skin Protectant

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.

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

ZO ®MEDICAL
BY ZEIN OBAGIMD

NDC 42851-083-12

REVITATROL™
Epidermal Repair Crème
Skin Protectant

Net Wt. 113 g / 4.0 Oz.

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
REVITATROL EPIDERMAL REPAIR SKIN PROTECTANT 
oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-083-121 in 1 CARTON02/17/201603/01/2021
1113 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:42851-083-561 in 1 CARTON02/01/201603/01/2021
258 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01602/01/201603/01/2021
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 1/2024
Document Id: 0180f008-77b0-5217-e063-6294a90a9d88
Set id: f7dfd7ad-96f9-487c-9b3c-efc9341ed2ff
Version: 3
Effective Time: 20240125
 
ZO Skin Health, Inc.