FAMILY WELLNESS MAXIMUM STRENGTH HYDROCORTISONE (HYDROCORTISONE) CREAM [FAMILY DOLLAR]

FAMILY WELLNESS MAXIMUM STRENGTH HYDROCORTISONE (HYDROCORTISONE) CREAM [FAMILY DOLLAR]
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NDC 55319-074-28
Set ID 15220ca4-b7de-4657-901a-114e260f0cf1
Category HUMAN OTC DRUG LABEL
Packager Family Dollar
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                                  Purpose

    Hydrocortisone, USP 1%.......................................Anti-Itch

  • PURPOSE

    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
    • seborrhea dermatitis
    • temporarily relieves external anal and genital itching
    • other uses for this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • in the genital area if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult a doctor.
  • WHEN USING

    When using this product

    • avoid contact with the eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put this product into the rectum by using finger or any mechanical device or applicator

  • STOP USE

    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.

  • INDICATIONS & USAGE

    Directions

    • for itching of 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
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature 20°-25°C (68°-77°F)
    • lot no. & exp. date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Family Dollar Services, Inc.

    10401 Monroe Rd.

    Matthews, NC 28105 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS MAXIMUM STRENGTH HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-074
    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)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-074-281 in 1 CARTON09/19/2016
    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 finalpart34808/19/2013
    Labeler - Family Dollar (024472631)

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