FAMILY WELLNESS (HYDROCORTISONE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]

FAMILY WELLNESS (HYDROCORTISONE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]
PDF | XML

NDC 55621-008-01
Set ID cddc9c4a-7c58-4225-921a-05d6afb49178
Category HUMAN OTC DRUG LABEL
Packager Zhejiang Jingwei Pharmaceutical Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • INACTIVE INGREDIENT

    Inactive Ingredients   white petrolatum

  • ACTIVE INGREDIENT

    Active Ingredient

    Hydrocortisone, USP 1%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    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

    -jewelry   -detergents   -cosmetics

    -psoriasis   -seborrheic dermatitis

    -for external genital, feminine and anal itching

    -other uses of this product should be only under the advice and

    supervision of 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.

  • WARNINGS

    Warnings

    For external use only.

    Do not use

    -in genital area if you have a 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 directed by a doctor

    -do not put this product into the rectum by using fingers or any other mechanical device or applicator

  • STOP USE

    Stop use and ask a doctor if

    -symptoms last for more than 7 days

    -the conditions get worse

    -symptoms clear up and then occur again within a few days

    -rectal bleeding occurs

  • DOSAGE & ADMINISTRATION

    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 or 4 times daily

    -for children under 2 years of age: ask a doctor

    for external anal and genital itching:

    adults:

    -clean the affected area with mild soap and warm water and rinse clean.

    -dry the affected area before applying

    -apply to the 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)

  • QUESTIONS

    Questions? 1-800-639-3803 Weekdays 9AM to 4 PM EST

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-008
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-008-0128 g in 1 TUBE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

Related Drugs