FLORASONE CREAM- cardiospermum halicacabum flowering top cream 
Schwabe Mexico, S.A. de C.V.

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 Cream

Active Ingredient

Contains 10% CARDIOSPERMUM HALICACABUM TINCTURE

Inactive Ingredients

BENZYL ALCOHOL

CETYL ALCOHOL

ETHYL ALCOHOL

GLYCERIN

GLYCOL STEARATE

ISOPROPYL MYRISTATE

MINERAL OIL

POTASSIUM HYDROXIDE

PURIFIED WATER

STEARYL HEPTANOATE

Dosage and 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.
Breasting-feeding women 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.

Overdosage

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 CREAM 
cardiospermum halicacabum flowering top cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-0003
Route of AdministrationTOPICAL, TOPICAL
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:68466-0003-41 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 Mexico, S.A. de C.V. (812805901)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(68466-0003)

Revised: 3/2023
Document Id: 026452f6-aab7-4e6e-94ba-2a961e7bf0ad
Set id: f3b58e17-d694-4846-8d14-f5e0dd230ecf
Version: 7
Effective Time: 20230322
 
Schwabe Mexico, S.A. de C.V.