FAMILY WELLNESS (HYDROCORTISONE 1%) CREAM [FRONT PHARMACEUTICAL PLC]

FAMILY WELLNESS (HYDROCORTISONE 1%) CREAM [FRONT PHARMACEUTICAL PLC]
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NDC 69571-009-01
Set ID ea26265d-f24e-458e-8bf0-287b2d49f4f4
Category HUMAN OTC DRUG LABEL
Packager FRONT PHARMACEUTICAL PLC
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients

    Hydrocortisone 1%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses

    •temporarily relieves itching associated with minor skin

    irritations, inflammation and rashes due to:

       •eczema  •psoriasis  •poison ivy, oak, sumac

       •insect bites  •detergents  •jewelry

       •cosmetics  •soaps  •saborrheiic dermatitis

    •temproarily relieves external and genital itching

    •other uses of this product should be under advice and

    supervision of a doctor

  • WARNINGS

    Warnings  For external use only.

    Do not use:

    •in the genital area if you have vaginal discharge. Consult a doctor.

    •for the treatment of diaper rash. Consult a doctor.

    When using this product:

    •avoid contact with eyes.

    •do not use more than directed unless told to do so by a doctor.

    •do not put directly into rectum by using fingers or

    any mechanical device or applicator.

    Stop use and ask a doctor if

    •condition worsens, symptoms persist for more than 7 days

    or clear up and occur again within a few days, and do not

    begin use of any other hydrocortisone product unless you

    have asked a doctor  •rectal bleeding occurs

  • 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 itching or skin irritation, inflammation and rashes:

       •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: ask a doctor

    •for external and genital itching, adults:

       •when practical, clean the affected area with mild soap

       and warm waterand rinse thoroughly

       •gently dry by patting or blotting with toilet tissue or soft

       cloth before applying

       •apply to affected area not more than 3 to 4 times daily

       •children under 12 years of age: ask a doctor

  • STORAGE AND HANDLING

    Other information

    •store at room temperature 68° - 77° F (20° - 25° C)

  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis leaf juice,

    ceteastrearyl alcohol, edetate disodium, glyceryl

    monostearate, methylparaben, mineral oil, polysorbate

    60, propylene glycol, span 60, water, white petrolatum

  • QUESTIONS

    Questions?  1-800-638-3800  Weekdays 0 AM to 4 PM EST

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    hydrocortisone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-009-011 in 1 CARTON06/18/2017
    128 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 finalpart34806/18/2017
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-009)

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