Label: TRAUMA FREE- symphytum officinale, bellis perennis, hypericum perforatum, magnesia phosphorica, ruta graveolens, arnica montana liquid
- NDC Code(s): 50164-0004-1
- Packager: Sago Natural Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated June 24, 2016
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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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:
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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:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
TRAUMA FREE
symphytum officinale, bellis perennis, hypericum perforatum, magnesia phosphorica, ruta graveolens, arnica montana liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50164-0004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 1 mL BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 12 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 12 [hp_X] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_X] in 1 mL RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 30 [hp_X] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 200 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50164-0004-1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/24/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/24/2016 Labeler - Sago Natural Products (123641693) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50164-0004) , api manufacture(50164-0004) , label(50164-0004) , pack(50164-0004)
