Label: EAR DISCOMFORT (aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, belladonna, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia phosphorica, plantago major, pulsatilla- pratensis, verbascum thapsus liquid
- NDC Code(s): 50845-0259-1
- Packager: Liddell Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
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 May 25, 2022
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ACTIVE INGREDIENTS:
(in each drop) 7.14% of Aconitum Napellus 200C, Anthracinum 200C, Arnica Montana 200C, Baptisia Tinctoria 3X, Belladonna 200C, Capsicum Annuum 6X, Chamomilla 3X, Chenopodium Anthelminticum 15X, Euphorbium Officinarum 6X, Lachesis Mutus 200C, Magnesia Phosphorica 10X, Plantago Major 3X, Pulsatilla (Pratensis) 30X, Verbascum Thapsus 6X.
- INDICATIONS:
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WARNINGS:
Stop use and ask a doctor if symptoms persist for more than 4 days, there is discharge from the ear, or there is a fever.
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
EAR DISCOMFORT
aconitum napellus, anthracinum, arnica montana, baptisia tinctoria, belladonna, capsicum annuum, chamomilla, chenopodium anthelminticum, euphorbium officinarum, lachesis mutus, magnesia phosphorica, plantago major, pulsatilla (pratensis), verbascum thapsus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0259 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 BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (UNII: 41LZ22DD4N) (BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - UNII:41LZ22DD4N) BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 200 [hp_C] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 200 [hp_C] in 1 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 3 [hp_X] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 200 [hp_C] in 1 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 6 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 3 [hp_X] in 1 mL DYSPHANIA AMBROSIOIDES WHOLE (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES WHOLE 15 [hp_X] in 1 mL EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN 6 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 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 PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 3 [hp_X] in 1 mL ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS 30 [hp_X] in 1 mL VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS 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:50845-0259-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 03/09/2020 01/02/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/09/2020 01/02/2025 Labeler - Liddell Laboratories, Inc. (832264241) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(50845-0259) , api manufacture(50845-0259) , label(50845-0259) , pack(50845-0259)