FDA.reportPublic FDA data

Florasone

Manufacturer
Schwabe North America | Schwabe Mexico, S.A. de C.V.
Effective date
2025-11-18
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 02:35:15

Label at a glance#

ProductFlorasone
Active ingredientCARDIOSPERMUM HALICACABUM FLOWERING TOP
Label structure12 sections

Indications and uses

Temporarily relieves itch, rash, and skin irritation/inflammation.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Contains 10% Cardiospermum halicacabum tincture

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Benzyl Alcohol

Cetyl Alcohol

Ethyl Alcohol

Glycerin

Glycol Stearate

Isopropyl Myristate

Mineral Oil

Potassium Hydroxide

Purified Water

Stearyl Heptanoate

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

Temporarily relieves itch, rash, and skin irritation/inflammation.

Purpose

OTC - PURPOSE SECTION

Temporarily relieves itch, rash, and skin irritation/inflammation.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes and broken skin.

Do Not Use

OTC - DO NOT USE SECTION

Do not use if hypersensitive to any ingredients in this product.

Breast-feeding woman should not apply to breast area.

Stop Use 

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

If swallowed, seek medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LHBN21850390.A01-Z-Florasone-Cream-1-oz.jpgLHBN21850390.A01-Z-Florasone-Cream-1-oz.jpg

LHT21850390.A01-Z-Florasone-Cream-1-oz.jpgLHT21850390.A01-Z-Florasone-Cream-1-oz.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130308078503905GTIN-13: 0308078503905
EAN-13: 0308078503905
GTIN-12: 308078503905
UPC-A: 308078503905
GTIN storage (14 digits): 00308078503905		LHBN21850390.A01-Z-Florasone-Cream-1-oz.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0390-4Florasone1 in 1 CARTONCREAM112
53499-0390-4Florasone28 g in 1 TUBECREAM2812

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARDIOSPERMUM HALICACABUM FLOWERING TOPACTIVE INGREDIENTMZP2508BRR2
CARDIOSPERMUM HALICACABUM FLOWERING TOPACTIVE MOIETYMZP2508BRR2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0E2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T2
STEARYL HEPTANOATEINACTIVE INGREDIENT2M4UGL1NCN2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-039053499-0390-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARDIOSPERMUM HALICACABUM FLOWERING TOPMZP2508BRRACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCOL STEARATE0324G66D0EIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MINERAL OILT5L8T28FGPIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
STEARYL HEPTANOATE2M4UGL1NCNIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ECREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCOL STEARATEGLYCOL STEARATE0324G66D0ECREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FlorasoneCARDIOSPERMUM HALICACABUM FLOWERING TOPSchwabe North America0ea5879c-5955-427d-8604-a0677a4bb5cd2025-11-18WarningsExact identifier
ndc (package): 53499-0390-4
ndc (product): 53499-0390
ndc11 (package): 53499039004
spl id: a15a9800-1914-4287-a3b4-2f399c318744
spl set id: 0ea5879c-5955-427d-8604-a0677a4bb5cd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.