TRAUMATONE- calendula officinalis, symphytum officinale, staphysagria, rhus toxicodendron, ruta graveolens, bellis perennis, 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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Traumatone

ACTIVE INGREDIENTS: Calendula officinalis 3X, Symphytum officinale 3X, Staphysagria 12X, Rhus toxicodendron 12X, Ruta graveolens 12X, Bellis perennis 12X, Ledum palustre 12X, Hypericum perforatum 12X, Strontium carbonicum 12X, Phosphorus 123X, Arnica montana 12X.

INDICATIONS: For temporary relief of soreness after exertion, pain and swelling in joints after strain or sprain, bruised joints and tendons.

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.

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

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.

INDICATIONS: For temporary relief of soreness after exertion, pain and swelling in joints after strain or sprain, bruised joints and tendons.

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.

Dist. by Energique, Inc.

201 Apple Blve.

Woodbine, IA 51579

800-869-8078

ENERGIQUE

TRAUMATONE

Homeopathic Remedy

1 fl. oz. (30 ml)

Traumatone

TRAUMATONE
calendula officinalis, symphytum officinale, staphysagria, rhus toxicodendron, ruta graveolens, bellis perennis, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0563
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	3 [hp_X] in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	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
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	12 [hp_X] in 1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	12 [hp_X] in 1 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	12 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	12 [hp_X] in 1 mL
STRONTIUM CARBONATE (UNII: 41YPU4MMCA) (STRONTIUM CATION - UNII:37077S2C93)	STRONTIUM CARBONATE	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	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:57520-0563-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/22/2010	09/09/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/22/2010	09/09/2022

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0563) , api manufacture(57520-0563) , label(57520-0563) , pack(57520-0563)

Revised: 4/2022

Document Id: dd845fdf-efdc-44da-a684-8d6c96f2e8e3

Set id: 7028d54a-4d61-4408-bcc2-a1cc18f135c7

Version: 2

Effective Time: 20220406

Apotheca Company