ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT- oatmeal lotion 
ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ZO ®MEDICAL REGENACELL™ 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, 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.

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.

PRINCIPAL DISPLAY PANEL - 120 mL Tube Label
ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT 
oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-080
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-080-12120 mL in 1 TUBE; Type 0: Not a Combination Product11/14/201412/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/14/201412/31/2020
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976manufacture(42851-080)

Revised: 7/2023
Document Id: 00de5a52-f0da-f08e-e063-6294a90a7e2d
Set id: 376f2589-d8da-4278-a46b-3e4778bee035
Version: 2
Effective Time: 20230719
 
ZO Skin Health, Inc.