NU-DERM TOLEREEN (HYDROCORTISONE) LOTION [OMP, INC.]

  • Home
  • NU-DERM TOLEREEN (HYDROCORTISONE) LOTION [OMP, INC.]

NU-DERM TOLEREEN (HYDROCORTISONE) LOTION [OMP, INC.]
PDF | XML
NDC 62032-112-36
Set ID f21778c7-d730-48a6-a0f9-5f6e550b8cf0
Category HUMAN OTC DRUG LABEL
Packager OMP, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Hydrocortisone, 0.5%

  • Purpose

    Anti-itch

  • Uses

    • Provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes from:
      • Eczema
      • Psoriasis
      • Insect bites
      • Seborrheic dermatitis
      • Soaps
      • Poison ivy
      • Poison oak
      • Poison sumac
      • Jewelry
      • Cosmetics
      • Detergents
    • Other uses of this product should be only under the advice and supervision of a doctor.
  • Warnings

    • For external use only.

    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

    • Adults and children 2 years and older: apply to the affected area not more than 3 to 4 times daily.
    • Children under 2 years of age, do not use, ask a doctor.
  • Other information

    • Store at room temperature. Protect from freezing and excessive heat.
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Related Drugs

Search DailyMed Drugs