Label: A BIT HIPPY- colloidal oatmeal 2% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 15, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Colloidal Oatmeal 2.0%

  • PURPOSE


    PURPOSE

    Skin protectant

    USES Temporarily protects and helps relieve minor skin irritation and itching due to eczema. For Symptomatic relief of Eczema for adult and children.

  • WARNINGS

    WARNINGS
    For external use only. When using this product do not get into eyes.

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN
    If swallowed, get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Apply as needed

  • SPL UNCLASSIFIED SECTION

    OTHER INFORMATION
    Store below 86°F or 30°C.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS
    Alcohol, Allantoin, Aloe Barbadensis Extract, Borago Officinalis, Seed Oil, Cetearyl Alcohol, Cocos Nucifera, Coconut Oil,
    Glycyrrhiza Glabra (Licorice), Root Extract, Hops Extract (Humulus Lupulus), Hydrocotyl Extract (Centella Asiatica), Hydrogenated Lecithin,
    Matricaria (Chamomilla Recutita ) Extract, Oenothera Biennis (Evening Primrose)Oil, Olive (Olea Europaea) Oil, Oryza Sativa (Rice) Bran Oil,
    Piroctone Olamine, Polysorbate 60, Squalane, Stearyl Glycyrrhetinate, Tocopheryl, Water, Xanthan Gum.

  • QUESTIONS

    QUESTIONS
    Phone (877) 521-2882
    www.abithippyusa.com

  • INDICATIONS & USAGE

    Temporarily protects and helps relieve minor skin irritation and itching due to eczema.

    For Symptomatic relief of Eczema for adult and children

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    A BIT HIPPY 
    colloidal oatmeal 2% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70315-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.2 g
    Inactive Ingredients
    Ingredient NameStrength
    RICE BRAN (UNII: R60QEP13IC)  
    GREEN OLIVE (UNII: 6HD2W46UEG)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    WHEAT BRAN (UNII: 6L966A1IMR)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    BORAGE (UNII: PB618V0K2W)  
    AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EUPHORBIA PEKINENSIS ROOT (UNII: 09S6R05TRN)  
    HOPS (UNII: 01G73H6H83)  
    OENOTHERA BIENNIS (UNII: 76UI55V071)  
    ALPHA-TOCOPHERYLQUINONE (UNII: ZO763K43XR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    ALCOHOL (UNII: 3K9958V90M)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SQUALANE (UNII: GW89575KF9)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    WATER (UNII: 059QF0KO0R)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70315-001-011 in 1 TUBE; Type 0: Not a Combination Product12/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/15/2015
    Labeler - A Bit Hippy (080055273)
    Registrant - A Bit Hippy (080055273)
    Establishment
    NameAddressID/FEIBusiness Operations
    A Bit Hippy080055273manufacture(70315-001)