Label: AVEDANA HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream

  • NDC Code(s): 43749-620-01, 43749-620-02
  • Packager: Unipack LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 4, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 gential, 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 solft cloth before application of this product.

    Children under 12 years of age: consult a doctor

  • Other information

    • Storage temperature: not to exceed 30 °C (86 °F). Protect from freezing.
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

    aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water.  May contain citric acid or sodium citrate solution to adjust pH.

  • Questions?

    724-733-7381

  • Avedana ® Hydrocortisone Cream with Aloe| 1oz Tube label

    Tube Label

  • Avedana ® Hydrocortisone Cream with Aloe| 1oz Carton label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    AVEDANA HYDROCORTISONE CREAM WITH ALOE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-620
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-620-021 in 1 CARTON04/07/2016
    1NDC:43749-620-0128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/07/2016
    Labeler - Unipack LLC (009248480)
    Registrant - Unipack LLC (116015769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(43749-620)