NU-DERM TOLEREEN  ANTI-PRURITIC- hydrocortisone lotion 
OMP, 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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OBAGI
NU-DERM®
TOLEREEN

Drug Facts

Active ingredients

Hydrocortisone, 0.5%

Purpose

Anti-itch

Uses

Warnings

Do not use

  • In the eyes.
  • For the treatment of diaper rash.

When using this product do not begin the use of any other hydrocortisone product.

Stop use and ask a doctor if

  • Symptoms last for more than 7 days.
  • The condition gets worse.
  • Symptoms clear up and come back in a few days.

Keep out of the reach of children.

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

Directions

Other information

Inactive ingredients

allantoin, butylparaben, cetyl alcohol, cyclopentasiloxane, glycerin, glyceryl stearate, lactic acid, methylparaben, PEG-100 stearate, propylparaben, purified water, saponins, stearyl alcohol, tetrasodium EDTA.

Dist. by OMP, Inc., Long Beach, CA 90802

PRINCIPAL DISPLAY PANEL - 57g Bottle Carton

OBAGI
NU-DERM®

TOLEREEN

ANTI-PRURITIC
LOTION

HYDROCORTISONE
USP, 0.5%

NET WT. 2 OZ. (57g)

Principal Display Panel - 57g Bottle Carton
NU-DERM TOLEREEN   ANTI-PRURITIC
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALLANTOIN (UNII: 344S277G0Z)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-112-361 in 1 BOX
157 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/01/1988
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Puretek Corporation785961046MANUFACTURE(62032-112) , LABEL(62032-112) , PACK(62032-112)

Revised: 10/2011
Document Id: 6e04ac42-958e-4163-a585-c9f9212801f6
Set id: f21778c7-d730-48a6-a0f9-5f6e550b8cf0
Version: 1
Effective Time: 20111026
 
OMP, Inc.