TRAUMA FREE- symphytum officinale, bellis perennis, hypericum perforatum, magnesia phosphorica, ruta graveolens, arnica montana liquid 
Sago Natural Products

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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Drug Facts:

ACTIVE INGREDIENTS:

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

INDICATIONS:

For temporary relief of pain, swelling and bruising.

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.

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.

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.

INACTIVE INGREDIENTS:

Demineralized water, Ethanol 25%.

QUESTIONS:

Manufactured for:

SAGO Natural Products

110 E. Main Ave.

Chewelah, WA 99109

PACKAGE LABEL DISPLAY:

NDC 50164-0004-1

TRAUMA FREE
DROPS

Homeopathic

2 fl. oz. (60 ml)

Trauma Free Drops

TRAUMA FREE 
symphytum officinale, bellis perennis, hypericum perforatum, magnesia phosphorica, ruta graveolens, arnica montana liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50164-0004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS12 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE30 [hp_X]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP30 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA200 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50164-0004-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/24/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/24/2016
Labeler - Sago Natural Products (123641693)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(50164-0004) , api manufacture(50164-0004) , label(50164-0004) , pack(50164-0004)

Revised: 6/2016
Document Id: 6b7e4683-5d6e-42f3-be8d-369df0e3561c
Set id: 8cc1c00c-6f37-49b5-88a8-4048c3a4fa96
Version: 1
Effective Time: 20160624
 
Sago Natural Products