Label: AFASSCO 1% HYDROCORTISONE- hydrocortisone ointment

  • NDC Code(s): 51532-4608-1, 51532-4608-2
  • Packager: Afassco Inc.
  • 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 12, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Hydrocorticone Cream 1%

  • ACTIVE INGREDIENT

    Active Ingredients (In Each Gram)

    Hydrocortisone 1%

  • PURPOSE

    Purpose 

    Anti-itch

  • INDICATIONS & USAGE

    Uses:

    • for the temporary temporarily 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
  • ASK DOCTOR

    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 worsens or if symptoms persist for more than 7 days or clear up and occur again in a few days
    • ask a doctor before use if you are using any other hydrocortisone product
  • WHEN USING

    When using this product:

    • avoid contacty with eyes
    • do not put this produce into rectum by using fingers or any mechanical device or applicator

  • 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 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 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 soft cloth before application of this product
    • Children under 12 years of age; for external 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, Cetearyl Alcohol, Glycerin,

    Ceteareth-20, Isopropyl Myristate,

    EDTA-2NA, Phenoxyethanol,

    Tocopheryl Acetate,

    Aloe Barbadensis Leaf Juice

  • Principal Display Panel

    Afassco¦ ¦®

    The First Choice
    in First Aid

    MAXIMUM STRENGTH
    HYDROCORTISONE
    PLUS MOISTURIZING ALOE

    1% ANTI-ITCH ANALGESIC • FOR THE

    TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

    No. 608                                25 ct.

    Afassco¦ ¦®

    The First Choice in First Aid

    REMOVE TOP FOR EASY ACCESS

    Compare To

    Hydrocortisone

    MAXIMUM STRENGTH
    HYDROCORTISONE

    1% ANTI-ITCH ANALGESIC • FOR THE

    TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

    No. 608                    25 ct.

    Afassco¦ ¦®

    The First Choice in First Aid

    MAXIMUM STRENGTH
    HYDROCORTISONE

    1% Crema de Fydrocortisona

    instructiones: Para Adultos y ninos

    2 anos y mas viejo.  Los ninos bajo

    2 anos, consultan un medico para

    picar anal externo.  Limpia el areaa

    afectada con jabon y aclarado

    aplique el producto.

    1% ANTI-ITCH ANALGESIC • FOR THE

    TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

    No. 608                      25 ct.

    Afassco¦ ¦®

    The First Choice in First Aid

    Manufactured for Afassco, Inc. Minden, NV 89423

    6   70254   60812   5

    ↓25 ct. Box↓

    Hydrocrtson 608 25ct

    ↓6 ct. Box↓

    Hydrocrtson 380 6ct

    ↓Unit Dose Package Label↓

    Afassco¦ ¦®

    The First Choice in First Aid

    1% Hydrocortisone

    Cream

    Manufactured for Afassco

    Minden, NV 89423

    1gm (1/32 oz)

     Made in China

    Hydrocort pouch

    res

  • INGREDIENTS AND APPEARANCE
    AFASSCO 1% HYDROCORTISONE 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-4608
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.01 g  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:51532-4608-125 in 1 BOX12/07/2018
    11 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:51532-4608-26 in 1 BOX12/07/2018
    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 finalpart34812/07/2018
    Labeler - Afassco Inc. (609982723)
    Registrant - Afassco Inc. (956159800)