Label: HYDROCORTISONE WITH ALOE- hydrocortisone with aloe anti itch cream

  • NDC Code(s): 13709-317-01, 13709-317-02
  • Packager: NeilMed Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 26, 2024

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  • Drug Facts

    Active Ingredients 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. 1-800-222-1222

  • 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 If pregnant or breast-feeding ■ ask a health professional before use.
    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:

    ■ 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 alchol, cetyl palmitate, glyceryl, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.

  • SAFE HANDLING WARNING

    TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

  • PRINCIPAL DISPLAY PANEL

    Hydrocream 1%

  • PRINCIPAL DISPLAY PANEL

    1oz

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE WITH ALOE 
    hydrocortisone with aloe anti itch cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-317
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-317-011 in 1 CARTON08/18/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:13709-317-021 in 1 CARTON08/18/2023
    256 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01508/18/2023
    Labeler - NeilMed Pharmaceuticals Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc.799295915manufacture(13709-317)