Label: EAR CARE- echinacea, hydrastis canadensis, apis mellifica, arsenicum album, belladonna, bryonia, capsicum annuum, causticum, cinchona officinalis, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali sulphuricum, lycopodium clavatum, mercurius vivus, mezereum, phosphorus, plantago major, pulsatilla, silicea, verbascum thapsus, tellurium metallicum, influenzinum liquid
- NDC Code(s): 55714-1537-1
- Packager: Newton 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 March 17, 2022
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- INDICATIONS AND USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Apis mellifica 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Dulcamara 15x, Ferrum phosphoricum 15x, Hepar sulphuris calcareum 15x, Kali sulphuricum 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Mezereum 15x, Phosphorus 15x, Plantago major 15x, Pulsatilla 15x, Silicea 15x, Tellurium metallicum 16x, Verbascum thapsus 15x, Influenzinum 30x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
EAR CARE
echinacea, hydrastis canadensis, apis mellifica, arsenicum album, belladonna, bryonia, capsicum annuum, causticum, cinchona officinalis, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali sulphuricum, lycopodium clavatum, mercurius vivus, mezereum, phosphorus, plantago major, pulsatilla, silicea, verbascum thapsus, tellurium metallicum, influenzinum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1537 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W) INFLUENZA B VIRUS 30 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 15 [hp_X] in 1 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 15 [hp_X] in 1 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 15 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 15 [hp_X] in 1 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 15 [hp_X] in 1 mL POTASSIUM SULFATE (UNII: 1K573LC5TV) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM SULFATE 15 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 15 [hp_X] in 1 mL DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK 15 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 15 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 15 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 15 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 15 [hp_X] in 1 mL TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ) TELLURIUM 16 [hp_X] in 1 mL VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS 15 [hp_X] in 1 mL INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS 30 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 15 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:55714-1537-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/07/2022 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-1537)
