Label: HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream

  • 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 March 1, 2021

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  • Drug Facts

  • Active ingredient

    Hydrocortisone, USP 1%

  • Purpose

    Anti-itch

  • Uses

    for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • jewelry
    • detergents
    • cosmetics
    • psoriasis
    • seborrheic dermatitis
    • for external genital, feminine and anal itching
    • other uses of this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only

  • Do not use

    • for external feminine itching if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult a doctor.
  • When using this product

    • avoid contact with the eyes

    • do not begin the use of any other hydrocortisone product unless directed by a doctor

    • for external anal itching:

      • do not use more than directed unless directed by a doctor 

      • do not put this product into the rectum by using fingers or any mechanical device or applicator

  • Stop use and ask a doctor if

    • symptoms last for more than 7 days
    • the condition gets worse
    • symptoms clear up and occur again in a few days
    • rectal bleeding occurs, consult doctor promptly
  • Keep out of reach of children. 

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

  • 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, consult a doctor

    For external anal itching

    Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

    Children under 12 years of age: consult a doctor

  • Other information

    • Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
    • Before using any medication, read all label directions.  Keep carton, it contains important information.
  • Inactive ingredients

    aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

  • Questions?

    1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

  • HOW SUPPLIED

    Product: 50090-3113

    NDC: 50090-3113-0 28 g in a TUBE / 1 in a CARTON

  • Hydrocortisone

    Label Image
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE WITH ALOE  MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3113(NDC:0904-7623)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3113-01 in 1 CARTON08/08/2017
    128 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 FINALpart34804/21/2009
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3113)
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