Label: FLORASONE- cardiospermum halicacabum flowering top 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 9, 2024

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  • Active Ingredient

    Contains 10% Cardiospermum halicacabum tincture

  • Inactive Ingredient

    Benzyl Alcohol

    Cetyl Alcohol

    Ethyl Alcohol

    Glycerin

    Glycol Stearate

    Isopropyl Myristate

    Mineral Oil

    Potassium Hydroxide

    Purified Water

    Stearyl Heptanoate

  • Dosage & Administration

    Directions

    Adults & children 6 years of age and older: apply to affected area up to 4 times daily; rub in gently. 

    Patch test recommended on sensitive skin.

  • Indications and Usage

    Temporarily relieves itch, rash, and skin irritation/inflammation.

  • Purpose

    Temporarily relieves itch, rash, and skin irritation/inflammation.

  • Warnings

    For external use only.

    Avoid contact with eyes and broken skin.

  • Do Not Use

    Do not use if hypersensitive to any ingredients in this product.

    Breast-feeding woman should not apply to breast area.

  • Stop Use 

    Stop use and ask a doctor if increased skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

    These could be signs of a serious condition.

  • Pregnancy or Breast-feeding

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out of reach of children

    Keep out of reach of children.

  • Overdose

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    LHBN21850390.A01-Z-Florasone-Cream-1-oz.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    FLORASONE 
    cardiospermum halicacabum flowering top cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP1 [hp_X]  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0390-41 in 1 CARTON01/01/2006
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2006
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-0390)
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