FLORASONE - cardiospermum halicacabum flowering top cream 
Nature's Way Products, Inc.

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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient:

Cardiospermum

Inactive Ingredients:

BENZYL ALCOHOL

CETYL ALCOHOL

GLYCOL STEARATE

GLYCERIN

ISOPROPYL MYRISTATE

MINERAL OIL

POTASSIUM HYDROXIDE

PURIFEID WATER

STEARYL HEPTANOATE

Dosage and Administration:

Boericke and Tafel Brand:

Directions:

Adults and Children 2 years of age and older: Apply to affected area a minimum of 3 to 4 times daily.  Rub in gently. 
Children under 2: Consult a doctor.

Indications and Usage:

For the temporary relief of itching and inflammation associated with minor skin irritations and rashes due to eczema, soaps, detergents, cosmetics and jewelry.

Purpose:

For the temporary relief of itching and inflammation associated with minor
skin irritations and rashes due to eczema, soaps, detergents, cosmetics and
jewelry.


Warnings: 

For external use only.  Avoid contact with eyes.  If condition worsens or if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.  Do not use this product if you are hypersensitive to cardiospermum.


Keep out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Package Label.Principal Display Panel:

Florasone 21850390 Carton
Florasone 21850390 Carton
FLORASONE 
cardiospermum halicacabum flowering top cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0390
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARDIOSPERMUM HALICACABUM FLOWERING TOP (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CARDIOSPERMUM HALICACABUM FLOWERING TOP1 [hp_X]  in 28 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
GLYCOL STEARATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
MINERAL OIL 
POTASSIUM HYDROXIDE 
WATER 
STEARYL HEPTANOATE 
Packaging
#Item CodePackage Description
1NDC:53499-0390-41 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2006
Labeler - Nature's Way Products, Inc. (153970520)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico SA DE CV824412357manufacture

Revised: 11/2010
Document Id: bdf98898-1bc4-4ef1-894e-0b1068a8834a
Set id: 0ea5879c-5955-427d-8604-a0677a4bb5cd
Version: 1
Effective Time: 20101109
 
Nature's Way Products, Inc.