ITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]

ITCH AND RASH CREAM (HYDROCORTISONE) CREAM [PROVISION MEDICAL PRODUCTS]
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NDC 69103-4506-3
Set ID 627b9ff5-5cc4-4abc-98f1-9650f41b7a67
Category HUMAN OTC DRUG LABEL
Packager Provision Medical Products
Generic Name
Product Class
Product Number
Application Number PART348
  • INDICATIONS & USAGE

    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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and

    scrapes

  • 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 for the treatment of diaper rash

    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 within a few days

    When using this product:avoid contact with eyes, do not put this product into rectum by using fingers or any mechanical


    Do not use:with any other Hydrocortison product unless you have consulted a doctor

  • DOSAGE & ADMINISTRATION

    dIRECTIONS:  fOR ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER-APPLY TO AFFECTED AREA NOT MORE THAN 3 OR 4 TIMES DAILY

    CHILDREN UNDER 2 YEARS, DO NOT USE, CONSULT A DOCTOR. ADULTS FOR EXTERNAL ANAL ITCHING WHEN PRACTICAL-CLEANSE THE AFFECTED AREA WITH A MILD SOAP AND WARM WATER AND RINCE THOROUGHLY OR BY PATTING AND BLOTTING WITH AN APPROPRIATE CLEANSING PAD. GENTLY DRY BY PATTING OR BLOTTING WITH A SOFT CLOTH BEFORE APPLICATION OF THIS PRODUCT.  CHILDREN UNDER 12 YEARS OF AGE-FOR EXTERNAL ANAL ITCHING, CONSULT A DOCTOR

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:CITRIC acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbat 80, propyl

    paraben, propylene glycol, purified water, sodium citrate, and titanium dioxide.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT (IN EACH GRAM)-HYDROCORTISONE 10 MG

  • PURPOSE

    ANTIPRURITIC (ANTI-ITCH)

  • PRINCIPAL DISPLAY PANEL

    HYDRO BOX

  • INGREDIENTS AND APPEARANCE
    ITCH AND RASH CREAM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-4506
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (SNOW WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-4506-325 in 1 CARTON04/03/2015
    1.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/31/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultraseal Corporation085752004pack(69103-4506)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(69103-4506)

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