Trauma Free Drops

Trauma Free Drops
SPL v1
SPL
SPL Set ID cc7dce86-f043-45e6-aa53-863246de8d16
Route
ORAL
Published
Effective Date 2011-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Comfrey Root (3 [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 2011-06-01

Description

ACTIVE INGREDIENTS:   Symphytum officinale 3X, Bellis perennis 12X, Hypericum perforatum 12X, Magnesia phosphorica 30X, Ruta graveolens 30X, Arnica montana 200X.


Medication Information

Warnings and Precautions

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.



Indications and Usage

INDICATIONS:  For temporary relief of pain, swelling and bruising.



Dosage and Administration

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 aer 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.



Description

ACTIVE INGREDIENTS:   Symphytum officinale 3X, Bellis perennis 12X, Hypericum perforatum 12X, Magnesia phosphorica 30X, Ruta graveolens 30X, Arnica montana 200X.

Section 50565-1

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



Section 51727-6

INACTIVE INGREDIENTS:  Demineralized water, Ethanol 25%.



Section 51945-4

NDC: 57520-0702-1

TRAUMA FREE DROPS

Homeopathic

1 fl. oz. (30 ml)

Section 53413-1

Manufactured for:

SAGO Natural Products

110 E. Main Ave.

Chewelah, WA 99109

1-877-935-2633



Section 55105-1

INDICATIONS:  For temporary relief of pain, swelling and bruising.



Section 55106-9

ACTIVE INGREDIENTS:  Symphytum officinale 3X, Bellis perennis 12X, Hypericum perforatum 12X, Magnesia phosphorica 30X, Ruta graveolens 30X, Arnica montana 200X.




Structured Label Content

Indications and Usage (34067-9)

INDICATIONS:  For temporary relief of pain, swelling and bruising.



Dosage and Administration (34068-7)

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 aer 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.



Warnings and Precautions (34071-1)

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.



Section 50565-1 (50565-1)

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



Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:  Demineralized water, Ethanol 25%.



Section 51945-4 (51945-4)

NDC: 57520-0702-1

TRAUMA FREE DROPS

Homeopathic

1 fl. oz. (30 ml)

Section 53413-1 (53413-1)

Manufactured for:

SAGO Natural Products

110 E. Main Ave.

Chewelah, WA 99109

1-877-935-2633



Section 55105-1 (55105-1)

INDICATIONS:  For temporary relief of pain, swelling and bruising.



Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:  Symphytum officinale 3X, Bellis perennis 12X, Hypericum perforatum 12X, Magnesia phosphorica 30X, Ruta graveolens 30X, Arnica montana 200X.




Advanced Ingredient Data


Raw Label Data

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