Label: NEOSPORIN ECZEMA ESSENTIALS ANTI ITCH- hydrocortisone cream

  • NDC Code(s): 58232-4010-1, 58232-4010-2
  • Packager: Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Hydrocortisone 1%

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  • Purpose

    Anti-itch

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  • Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
      • eczema
      • soaps
      • detergents
      • cosmetics
      • seborrheic dermatitis
      • psoriasis
    • other uses of this product should only be under the advice and supervision of a doctor
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  • Warnings

    For external use only.

    Do not use for the treatment of diaper rash. Consult a doctor.

    When using this product avoid contact with eyes

    Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

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

    • store at 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

    water, petrolatum, glycerin, mineral oil, ceteareth-6, dimethicone, VP/eicosene copolymer, stearyl alcohol, phenoxyethanol, ammonium acryloyldimethyltaurate/VP copolymer, cetyl alcohol, carbomer, edetate disodium, methylparaben, sodium citrate, dipropylene glycol, ethylparaben, propylparaben, citric acid, ethylene brassylate, oat kernel extract, dihydrocitronellol, boswellia serrata resin extract, cis-3-hexenyl salicylate, sodium hydroxide1


    1
    may contain this ingredient
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  • Questions?

    call 1-800-223-0182

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  • SPL UNCLASSIFIED SECTION

    DIST: JOHNSON & JOHNSON
    CONSUMER PRODUCTS COMPANY
    Division of Johnson & Johnson Consumer
    Companies, Inc., Skillman, NJ 08558-9418

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  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    NEW
    FROM THE #1 DOCTOR RECOMMENDED BRAND®

    NEOSPORIN®
    ECZEMA
    ESSENTIALS™

    Hydrocortisone
    Anti-itch Cream

    Dual action formula

    Fast relief of itch flare-
    ups due to eczema
    Moisturizes to restore
    visibly healthier skin

    Maximum Strength
    Fragrance-free

    RELIPID™
    FORMULA
    NET WT 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    NEOSPORIN ECZEMA ESSENTIALS   ANTI ITCH
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58232-4010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) Hydrocortisone 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Petrolatum  
    Glycerin  
    Mineral Oil  
    Dimethicone  
    Stearyl Alcohol  
    Phenoxyethanol  
    Cetyl Alcohol  
    Edetate Disodium  
    Methylparaben  
    Sodium Citrate  
    Dipropylene Glycol  
    Ethylparaben  
    Propylparaben  
    Citric Acid Monohydrate  
    Ethylene Brassylate  
    Oat  
    3,7-Dimethyloctanal  
    Indian Frankincense  
    Sodium Hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58232-4010-2 8.5 g in 1 TUBE
    2 NDC:58232-4010-1 1 in 1 CARTON
    2 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 09/30/2011
    Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)
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