Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 7c7eb5bd-6376-49ea-8be6-8ea6e7f8336f
Route
ORAL
Published
Effective Date 2016-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Comfrey Root (6 [hp_X]) Bellis Perennis (12 [hp_X]) Hypericum Perforatum (30 [hp_X]) Magnesium Cation (200 [hp_X]) Ruta Graveolens Flowering Top Arnica Montana
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-06-24

Description

Symphytum Officinale 6X, Bellis Perennis 12X, Hypericum Perforatum 12X, Magnesia Phosphorica 30X, Ruta Graveolens 30X, Arnica Montana 200X.


Medication Information

Description

Symphytum Officinale 6X, Bellis Perennis 12X, Hypericum Perforatum 12X, Magnesia Phosphorica 30X, Ruta Graveolens 30X, Arnica Montana 200X.

Warnings:

If pregnant or nursing, consult a health professional before use.

Keep cap closed tightly.

Do not store near computers or in temperature over 100 degrees.

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.

Questions:

Manufactured for:

SAGO Natural Products

110 E. Main Ave.

Chewelah, WA 99109

Directions:

For acute symptoms place 15 drops in mouth every 15-30 minutes for 2 hrs. then reduce to 3 to 4 times daily upon improvement. Continue until symptoms are relieved. Children: 3-10 yrs. use 1/2 adult dose. Avoid peppermint, spearmint, menthol or caffeine for at least 1 hr. Remedies may be diluted in 2 tbsp. of pure water. If symptoms worsen or persist for more than 7 days, consult a licensed practitioner. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of pain, swelling and bruising.

Active Ingredients:

Symphytum Officinale 6X, Bellis Perennis 12X, Hypericum Perforatum 12X, Magnesia Phosphorica 30X, Ruta Graveolens 30X, Arnica Montana 200X.

Inactive Ingredients:

Demineralized water, Ethanol 25%.

Package Label Display:

NDC 50164-0003-1

TRAUMA FREE

DROPS

Homeopathic

1 fl. oz. (60 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Warnings: (WARNINGS:)

If pregnant or nursing, consult a health professional before use.

Keep cap closed tightly.

Do not store near computers or in temperature over 100 degrees.

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.

Questions: (QUESTIONS:)

Manufactured for:

SAGO Natural Products

110 E. Main Ave.

Chewelah, WA 99109

Directions: (DIRECTIONS:)

For acute symptoms place 15 drops in mouth every 15-30 minutes for 2 hrs. then reduce to 3 to 4 times daily upon improvement. Continue until symptoms are relieved. Children: 3-10 yrs. use 1/2 adult dose. Avoid peppermint, spearmint, menthol or caffeine for at least 1 hr. Remedies may be diluted in 2 tbsp. of pure water. If symptoms worsen or persist for more than 7 days, consult a licensed practitioner. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of pain, swelling and bruising.

Active Ingredients: (ACTIVE INGREDIENTS:)

Symphytum Officinale 6X, Bellis Perennis 12X, Hypericum Perforatum 12X, Magnesia Phosphorica 30X, Ruta Graveolens 30X, Arnica Montana 200X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, Ethanol 25%.

Package Label Display: (PACKAGE LABEL DISPLAY:)

NDC 50164-0003-1

TRAUMA FREE

DROPS

Homeopathic

1 fl. oz. (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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


Advanced Ingredient Data


Raw Label Data

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