WELLY ITCH FIX (HYDROCORTISONE ANTI ITCH CREAM) CREAM [WELLY HEALTH PBC]

WELLY ITCH FIX (HYDROCORTISONE ANTI ITCH CREAM) CREAM [WELLY HEALTH PBC]
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NDC 72663-155-50
Set ID 0965a0ed-c8a2-4ce8-a873-287a60078d47
Category HUMAN OTC DRUG LABEL
Packager Welly Health PBC
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone 1.0%

  • Purpose

    Anti-itch

  • Uses

    For 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
    • psoriasis
    • external feminine, genital 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 the treatment of diaper rash, consult a doctor.
    • for external genital itching if you have a vaginal discharge, consult a doctor.

    When using this product

    • avoid contact with eyes
    • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
    • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult 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

    • If condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

    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 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 cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • children under 12 years of age with external anal itching: consult a doctor.
  • Other information

    store at controlled room temperature 68° - 77ºF (20°-25°C).

  • Inactive ingredients

    Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water

  • Principal Display Panel – Can Label

    Welly First Aid Itch Fix 

    NDC 72663-155-50

    Hydrocortisone 1% Anti-itch Cream

    2 tubes -0.57 oz(16g)   Total Net Wt 1.14oz (32g)

    Principal Display Panel – Can Label

  • Principal Display Panel – 0.57oz Tube Label

    NDC 72663-155-50    Welly First Aid Itch fix

    Hydrocortisone 1% Anti-itch Cream  Net Wt. 0.57 oz (16g)

    Principal Display Panel – 0.57oz Tube Label

  • INGREDIENTS AND APPEARANCE
    WELLY ITCH FIX 
    hydrocortisone anti itch cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-155
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-155-502 in 1 CAN02/22/2019
    116 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 finalpart34802/22/2019
    Labeler - Welly Health PBC (116766884)
    Registrant - Welly Health PBC (116766884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(72663-155)

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