FLUTONE- baptisia tinctoria, echinacea, hydrastis canadensis, phytolacca decandra, arsenicum album, bryonia, eupatorium perfoliatum, ferrum phosphoricum, gelsemium sempervirens, ipecacuanha, rhus toxicodendron, liquid
Apotheca Company

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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Flutone

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.

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: 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.

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 INGREDIENTS: Demineralized water, 20% Ethanol.

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

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.

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

ENERGIQUE

FLUTONE

Homeopathic Remedy

1 fl. oz. (30 ml)

Flutone

FLUTONE
baptisia tinctoria, echinacea, hydrastis canadensis, phytolacca decandra, arsenicum album, bryonia, eupatorium perfoliatum, ferrum phosphoricum, gelsemium sempervirens, ipecacuanha, rhus toxicodendron, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0663
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X] in 1 mL
ECHINACEA (UNII: 4N9P6CC1DX) (ECHINACEA - UNII:4N9P6CC1DX)	ECHINACEA	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	12 [hp_X] in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	12 [hp_X] in 1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	12 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X] in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0663-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/18/2011	09/03/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/18/2011	09/03/2022

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0663) , api manufacture(57520-0663) , label(57520-0663) , pack(57520-0663)

Revised: 4/2022

Document Id: 82d178de-a2ac-4919-afcb-e35796ca45c3

Set id: 57de004b-62c6-41b8-a9cf-c91699fe879a

Version: 2

Effective Time: 20220408

Apotheca Company