ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE (HYDROCORTISONE) CREAM [NATURAL ESSENTIALS, INC.]

ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE (HYDROCORTISONE) CREAM [NATURAL ESSENTIALS, INC.]
PDF | XML

NDC 66902-228-03
Set ID fbdc6c18-9c1d-4b35-bb08-91bcdae8f983
Category HUMAN OTC DRUG LABEL
Packager NATURAL ESSENTIALS, INC.
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT:

    Hydrocortisone 1%

  • PURPOSE:

    Anti-itch

  • 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
      • seborrheic
      • dermatitis
    • Other uses of this product should be only under the advice and supervision of a doctor.
  • WARNINGS:

    For external use only.

    • 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 directly into the 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 clears up and occur again within a few days
    • do not begin use of any hydrocortisone product unless you have asked a doctor
    • If rectal bleeding occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 2 to 3 times daily.
    • Children Under 2 Years of Age: Ask a doctor.
    • For External Anal and Genital Itching, Adults:
    • When practical, dean the affected area with mild soap and warm water and rinse thoroughly.
    • Gently dry by patting or blotting with toilet tissue or a soft doth before applying.
    • Apply to affected area not more than 2 to 3 times dally.
    • Children Under 12 Years of Age: Ask a doctor.
    • Store at 20-25 degrees C / 68-77 degrees F.
  • INACTIVE INGREDIENTS:

    Water, Aloe Barbadensis Leaf Juice, SD Alcohol 3-C, Propylene Glycol, Cetearyl Alcohol, Isocetyl Stearate, Caprylic/Capric Triglyceride, Pimenta Acris (Bay) Leaf Oil, Isostearyl Palmitate, Cetyi Palmitate, Arnica Montana Flower Extract, Carbomer, Glyceryl Stearate, Ceteth-20, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Methylparaben, Diazolidinyl Urea, lodopropynyl Butylcarbamate.

  • Principal Display Panel - Tube Label

    NEW!

    ZIM'S®
    ADVANCED

    CRACK
    CREME

    Organic

    ALOE AND
    ARNICA
    with HYDROCORTISONE

    Dry, Cracked Skin
    Rashes, Inflammation
    Redness
    Insect Bites
    Eczema, Psoriasis

    DEVELOPED BY A PHARMACIST

    Net Wt 3 oz (85g)

    Principal Display Panel - Tube Label
  • INGREDIENTS AND APPEARANCE
    ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-228
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    BAY LEAF OIL (UNII: 5UMH0U3W0V)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STEARYL PALMITATE (UNII: 214W90O2XZ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-228-031 in 1 TUBE
    10.00085 L in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2014
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-228)

Related Drugs