Florasone Cream
FDA Label NDC 53499-0390

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America for the product Florasone (NDC 53499-0390). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, dosage & administration, indications and usage, purpose, warnings, do not use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

CARDIOSPERMUM HALICACABUM TINCTURE

Inactive Ingredient

BENZYL ALCOHOL
CETYL ALCOHOL

GLYCERIN
GLYCOL STEARATE
ISOPROPYL MYRISTATE
MINERAL OIL
POTASSIUM HYDROXIDE
PURIFIED WATER
STEARYL HEPTANOATE

Dosage & Administration

Directions:

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.

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.

Ask Doctor

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.

* Please review the disclaimer below.