Label: NU-DERM TOLEREEN- hydrocortisone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated October 26, 2011

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  • 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)
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