Label: MAXIMUM STRENGTH HYDROCORTISONE PLUS MOISTURIZING ALOE- 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 May 21, 2021

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

  • Drug Facts

    Active Ingredients:
    Hydrocortisone Cream 1%
    Active Ingredients (In Each Gram)

  • PURPOSE

    Purpose
    Hydrcortisone 1% ...... Anti Itch

  • INDICATIONS & USAGE

    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, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis
    scrapes • for external genital, feminine, and anal itching • other uses of this product
    should be only under the advice and supervision of a doctor

  • WARNINGS

    Warnings • for external use only • avoid contact with eyes • do not put this product
    into rectum by using fingers or any mechanical device or applicator Consult a doctor:
    • before use if you have a vaginal discharge (for external feminine itching) • for
    external itching, do not exceed the recommended daily dosage or if bleeding occurs •
    if condition When using this product: • avoid contact with eyes • do not put this
    product into rectum by using fingers or any mechanical device or applicator worsens
    or if symptoms persist for more than 7 days or clear up and occur again within a few
    days • ask a doctor before use if you are using any other hydrocortisone product

  • DO NOT USE

    Do Not Use • with any other Hydrocortisone product unless you have consulted a
    doctor

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
    contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: • For 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 • Adults for external anal itching when practical, cleanse the affected area with
    mild soap and warm water and rinse thoroughly or by patting or blotting with an
    appropriate cleansing pad • Gently dry by patting or blotting with toilet tissue or a
    soft cloth before application of this product • Children under 12 years of age: for
    external anal itching, consult a doctor

  • OTHER SAFETY INFORMATION

    Other Information: • Store at controlled
    room temperature 15° to 30° C
    (59° to 86° F) • Tamper evident. Do not
    use if packet is torn, cut, or opened
    • Avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cetaryl
    Alcohol, Glycerin, Ceteareth-20,
    Isopropyl Mistrate, EDTA-2NA,
    Phenoxyethanol, Tocopheryl Acetate,
    Aloe Barbadensis leaf Juice

  • Product Package

    aramark

    25 ct. of 1g packets

    Part # 608R23

    MAXIMUM STRENGTH
    HYDROCORTISONE
    PLUS MOISTURIZING ALOE

    compare to
    Hydrocortisone

    1% ANTI-ITCH ANALGESIC • FOR THE

    TEMPORARY RELIEFOF MINOR SKIN IRRITATIONS

    Retain carton for complete product information

    MANUFACTURED BY:
    Aramark
    Lenexa, KS 66219 (913) 269-9611

    aramarkuniform.com

    25 Count

    4608-1 25Ct

    6 Count

    4608-2 6Ct

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH HYDROCORTISONE PLUS MOISTURIZING ALOE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-4608
    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
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-4608-125 in 1 BOX04/16/2021
    11 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:81238-4608-26 in 1 BOX04/16/2021
    21 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/16/2021
    Labeler - Western First Aid Safety dba Aramark (043861524)
    Registrant - Western First Aid Safety dba Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co., Ltd.529892305manufacture(81238-4608)