FLORASONE- cardiospermum halicacabum flowering top cream 
Schwabe North America

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.

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Florasone

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 show 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.

LBN21850390_A02_Florasone_1oz_CTN_FNL.jpg

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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)

Revised: 3/2023
Document Id: ecf0674b-97d7-4d0a-8e3d-141e7d551096
Set id: 0ea5879c-5955-427d-8604-a0677a4bb5cd
Version: 10
Effective Time: 20230322
 
Schwabe North America