Label: AVEDANA HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream

  • NDC Code(s): 43749-621-01, 43749-621-03
  • Packager: Unipack 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 January 18, 2023

If you are a consumer or patient 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
  • 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?

    Call 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:43749-621
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-621-011 in 1 CARTON08/27/2021
    1NDC:43749-621-0328 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 finalpart34808/27/2021
    Labeler - Unipack LLC (009248480)
    Registrant - Unipack LLC (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(43749-621)