Label: PAIN (aconitum napellus, arnica montana, bellis perennis, bryonia- alba, cartilago suis, causticum, chamomilla, coffea cruda, euphorbium officinarum, gnaphalium polycephalum, hypericum perforatum, magnesia phosphorica, passiflora incarnata, pyrogenium, ranunculus bulbosus, symphytum officinale spray
- NDC Code(s): 50845-0265-1
- 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 December 19, 2023
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ACTIVE INGREDIENTS:
(in each spray): 6.25% of Aconitum Napellus 200C, Arnica Montana 3X, Bellis Perennis 3X, Bryonia (Alba)12X, Cartilago Suis 6X, Causticum 200X, Chamomilla 3X, Coffea Cruda 200C, Euphorbium Officinarum 6X, Gnaphalium Polycephalum 3X, Hypericum Perforatum 200C, Magnesia Phosphorica 12X, Passiflora Incarnata 1X, Pyrogenium 200C, Ranunculus Bulbosus 6X, Symphytum Officinale 6X.
- INDICATIONS:
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WARNINGS:
If symptoms persist for more than 7 days, consult a doctor.
If pregnant or breast feeding, ask a doctor before use.
Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.
Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
PAIN
aconitum napellus, arnica montana, bellis perennis, bryonia (alba), cartilago suis, causticum, chamomilla, coffea cruda, euphorbium officinarum, gnaphalium polycephalum, hypericum perforatum, magnesia phosphorica, passiflora incarnata, pyrogenium, ranunculus bulbosus, symphytum officinale sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0265 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE 200 [hp_C] in 1 mL ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 3 [hp_X] in 1 mL BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE 3 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 12 [hp_X] in 1 mL SUS SCROFA CARTILAGE (UNII: 73ECW5WG2F) (SUS SCROFA CARTILAGE - UNII:73ECW5WG2F) SUS SCROFA CARTILAGE 6 [hp_X] in 1 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 200 [hp_C] in 1 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 3 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 200 [hp_C] in 1 mL EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN 6 [hp_X] in 1 mL PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE 3 [hp_X] in 1 mL HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM WHOLE - 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 12 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 1 [hp_X] in 1 mL RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF 200 [hp_C] in 1 mL RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS WHOLE - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS WHOLE 6 [hp_X] in 1 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [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:50845-0265-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/26/2020 Labeler - Liddell Laboratories, Inc. (832264241) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50845-0265) , api manufacture(50845-0265) , label(50845-0265) , pack(50845-0265)