Label: BACK PAIN AND SCIATICA- aconitum napellus, arnica montana, belladonna, cimicifuga racemosa, euphorbium officinarum, gelsemium sempervirens, gnaphalium polycephalum, hypericum perforatum, magnesia phosphorica, phytolacca decandra, ranunculus bulbosus, rhus tox spray
- NDC Code(s): 50845-0044-1, 50845-0044-2
- Packager: Liddell Laboratories, Inc.
- 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 November 11, 2024
If you are a consumer or patient please visit this version.
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ACTIVE INGREDIENTS:
Aconitum napellus 200C, Arnica montana 200C, Belladonna 6X, Cimicifuga racemosa 6X, Euphorbium officinarum 6X, Gelsemium sempervirens 6X, Gnaphalium polycephalum 30X, Hypericum perforatum 200C, Magnesia phosphorica 10X, Phytolacca decandra 3X, Ranunculus bulbosus 30C, Rhus tox 200C.
(Symptom relief for back pain and sciatica**)
- USES:
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WARNINGS:
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.
Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.
If pregnant or breast feeding, ask a doctor before using product.
Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.
OTHER INFORMATION: Store at room temperature.
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- KEEP OUT OF REACH OF CHILDREN:
- INDICATIONS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
BACK PAIN AND SCIATICA
aconitum napellus, arnica montana, belladonna, cimicifuga racemosa, euphorbium officinarum, gelsemium sempervirens, gnaphalium polycephalum, hypericum perforatum, magnesia phosphorica, phytolacca decandra, ranunculus bulbosus, rhus tox sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0044 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 200 [hp_C] in 1 mL ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 200 [hp_C] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_X] in 1 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 6 [hp_X] in 1 mL EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN 6 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE 30 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 200 [hp_C] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 3 [hp_X] in 1 mL RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS WHOLE 30 [hp_C] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 200 [hp_C] 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:50845-0044-2 1 in 1 CARTON 01/25/2017 12/31/2024 1 NDC:50845-0044-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/05/2011 12/31/2024 Labeler - Liddell Laboratories, Inc. (832264241) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50845-0044) , api manufacture(50845-0044) , label(50845-0044) , pack(50845-0044)
