Florasone: Homeopathic Product Information

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.

´╗┐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

Adults and Children 2 years of age and older:Apply to affected area up to 4 times daily. Rub in gently.

Children under 2 years if age: Consult a doctor.

Patch test recommended on sensitive skin.

Florasone 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 immediately.

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FLORASONE
cardiospermum halicacabum flowering top cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-0390
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARDIOSPERMUM HALICACABUM FLOWERING TOP (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CARDIOSPERMUM HALICACABUM FLOWERING TOP 1 [hp_X] in 28 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
GLYCOL STEARATE
GLYCERIN
ISOPROPYL MYRISTATE
MINERAL OIL
POTASSIUM HYDROXIDE
WATER
STEARYL HEPTANOATE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-0390-4 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (53499-0390-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/01/2006
Labeler — Schwabe North America (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe Mexico, S.A. de C.V. 812805901 manufacture (53499-0390)

Revised: 09/2021 Schwabe North America

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