Label: PREPARATION H SOOTHING RELIEF ANTI-ITCH- hydrocortisone cream

  • NDC Code(s): 0573-0552-11
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 July 19, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient

    Hydrocortisone 1%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses

    temporary relief of external anal itching
    temporary relief of itching associated with minor skin irritations and rashes
    other uses of this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only

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

    When using this product

    avoid contact with the eyes
    do not exceed the recommended daily dosage unless directed by a doctor
    do not put into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    bleeding occurs
    condition worsens
    symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
    when first opening the tube, puncture foil seal with top end of cap
    adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
    children under 12 years of age: do not use, consult a doctor
  • STORAGE AND HANDLING

    Other information

    store at 20–25°C (68–77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum

  • QUESTIONS

    Questions or comments?

    Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

  • PRINCIPAL DISPLAY PANEL - 26 g Tube Label

    PREPARATION H®

    soothing
    RELIEF
    anti-itch cream

    HYDROCORTISONE 1%

    Maximum Strength
    Without a Prescription

    Effective Itch Relief

    No Added Fragrance

    NET WT 0.9 OZ (26 g)

    PRINCIPAL DISPLAY PANEL - 26 g Tube Label
  • PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

    NEW!

    PREPARATION H®

    soothing
    RELIEF
    anti-itch cream

    HYDROCORTISONE 1%

    Maximum Strength
    Without a Prescription

    Effective Itch Relief

    No Added Fragrance

    ONE TUBE / NET WT 0.9 0Z (26 g)

    PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PREPARATION H SOOTHING RELIEF ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (off-white viscous cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0552-111 in 1 CARTON02/28/2020
    126 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34802/28/2020
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)