FDA.reportPublic FDA data

Flutone

Manufacturer
Apotheca Company
Effective date
2022-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:03:55

Label at a glance#

ProductFlutone
Active ingredientBAPTISIA TINCTORIA ROOT, ECHINACEA, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, TOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:Baptisia tinctoria 3X, Echinacea 3X, Hydrastis canadensis 3X, Phytolacca decandra 3X, Arsenicum album 12X, Bryonia 12X, Eupatorium perfoliatum 12X, Ferrum phosphoricum 12X, Gelsemium sempervirens 12X, Ipecacuanha 12X, Rhus toxicodendron 12X.

OTC - PURPOSE SECTION

INDICATIONS:  For temporary relief of minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough, chilliness, and headaches.

WARNINGS SECTION

WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place.

DOSAGE & ADMINISTRATION SECTION

SUGGESTED USE:  Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.  If symptoms persist, consult your health care professional.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:  Demineralized water, 20% Ethanol.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

INDICATIONS:  For temporary relief of minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough, chilliness, and headaches.

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

FLUTONE

Homeopathic Remedy

1 fl. oz. (30 ml)

FlutoneFlutone

FlutoneFlutone

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0663-12022-04-08C16284748780-19d75b9cf-f881-f424-e053-dadaa90a57ceFlutone
57520-0663-12020-01-31C16284748780-19d75b9cf-f881-f424-e053-dadaa90a57ceFlutone

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
ECHINACEAACTIVE INGREDIENT4N9P6CC1DX1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6E1
FERRUM PHOSPHORICUMACTIVE INGREDIENT91GQH8I5F71
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV1
IPECACACTIVE INGREDIENT62I3C8233L1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HO1
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
ECHINACEAACTIVE MOIETY4N9P6CC1DX1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6E1
FERRUM PHOSPHORICUMACTIVE MOIETY91GQH8I5F71
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
GOLDENSEALACTIVE MOIETYZW3Z11D0JV1
IPECACACTIVE MOIETY62I3C8233L1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57520-066357520-0663-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ECHINACEA4N9P6CC1DXACTIB
GOLDENSEALZW3Z11D0JVACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
FERRUM PHOSPHORICUM91GQH8I5F7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
IPECAC62I3C8233LACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
WATER059QF0KO0RIACT
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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 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
82d178de-a2ac-4919-afcb-e35796ca45c357de004b-62c6-41b8-a9cf-c91699fe879a2022-04-08WarningsExact identifier
spl id: 82d178de-a2ac-4919-afcb-e35796ca45c3
spl set id: 57de004b-62c6-41b8-a9cf-c91699fe879a

Reported adverse events (FAERS/openFDA)#

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