| NDC | 50845-0237-1 |
| Set ID | 2ae11146-b869-4a53-afa3-805de12921f9 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Liddell Laboratories, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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ACTIVE INGREDIENTS:
(in each spray) 8.33% of 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 4X, 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.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- 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:50845-0237 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 200 [hp_C] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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 (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM 30 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 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 4 [hp_X] in 1 mL RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS 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:50845-0237-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/30/2019 Labeler - Liddell Laboratories, Inc. (832264241) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50845-0237) , api manufacture(50845-0237) , label(50845-0237) , pack(50845-0237)
