Label: SCIATICA THERAPY- arnica montana - citrullus colocynthis fruit pulp - pseudognaphalium obtusifolium - hypericum perforatum - potassium iodide - magnesium phosphate, dibasic trihydrate - toxicodendron pubescens leaf - tablet, orally disintegrating
- NDC Code(s): 17312-021-14
- Packager: TRP Company
- 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 March 5, 2024
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose Arnica Montana HPUS 6x, 12x, 18x Back aches
Colocynthis HPUS 6x, 12x, 18x Nerve discomfort
Gnaphalium polycephalum HPUS 6X, 12x, 18x Leg numbness Hypericum perforatum HPUS 6X, 12x, 18x Tingling legs Kali iodatum HPUS 6X, 12x, 18x Lumbar tenderness
Magnesia phosphorica HPUS 6X, 12x, 18x Shooting discomfort
Rhus toxicodendron HPUS 6X, 12x, 18x Stiffness, Difficulty moving
The letters HPUS indicate that the components of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
- PURPOSE
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INDICATIONS & USAGE
Uses:
According to homeopathic indications these ingredients provide temporary relief from symptoms of Sciatica such as: • back aches • nerve discomfort • leg numbness • tingling legs • shooting discomfort • stiffness • tearing pain after serious causes have been ruled out by a physician.* These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
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WARNINGS
Warnings:
A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES.- This product is intended to complement, not replace, standard medical treatment.
- Initial worsening of symptoms may occur.
- A physician should always be consulted regarding Sciatica to rule out serious causes.
- In case of overdose, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if: • Symptoms persist for more than 7 days or worsen, if new symptoms occur or if redness or swelling is present because these could be a sign of a serious illness.
- Keep out of reach of children
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions:
- Suitable for adults and children ages 2 and over.
- Children under the age of 2: consult a physician before use.
- Dissolve entire tablet under tongue.
- Do not chew or swallow whole.
- Take 1 tablet 3 times a day or as directed by a physician.
- Use up to 6 times a day as needed.
- Take at least 10 minutes before or at least 10 minutes after eating or drinking.
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- Do not use if tamper evident seal is torn, broken or missing.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SCIATICA THERAPY
arnica montana - citrullus colocynthis fruit pulp - pseudognaphalium obtusifolium - hypericum perforatum - potassium iodide - magnesium phosphate, dibasic trihydrate - toxicodendron pubescens leaf - tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X] PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM 6 [hp_X] HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 6 [hp_X] POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 6 [hp_X] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] Inactive Ingredients Ingredient Name Strength COPOVIDONE (UNII: D9C330MD8B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SORBITOL (UNII: 506T60A25R) CROSPOVIDONE (UNII: 68401960MK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape DIAMOND Size 13mm Flavor Imprint Code TRP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-021-14 1 in 1 PACKAGE 12/01/2011 1 70 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2011 Labeler - TRP Company (105185719)
