Label: EAR CARE- influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, austicum, cinchona, conium,dulcamara, ferrum phosphoricum, hepar sulph. calc.,kali sulph., ycopodium, merc. viv., mezereum,phosphorus, plantago, pulsatilla, silicea,verbascum, echinacea, hydrastis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-1504-0, 55714-1504-1, 55714-1504-2 - 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 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Influenzinum 30x, Tellurium metallicum 15x, Apis mel. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Capsicum 10x, Causticum 10x, Cinchona 10x, Conium 10x, Dulcamara 10x, Ferrum phosphoricum 10x, Hepar sulph. calc. 10x, Kali sulph. 10x, Lycopodium 10x, Merc. viv. 10x, Mezereum 10x, Phosphorus 10x, Plantago 10x, Pulsatilla 10x, Silicea 10x, Verbascum 10x, Echinacea 3x, Hydrastis 3x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - 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
influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, austicum, cinchona, conium,dulcamara, ferrum phosphoricum, hepar sulph. calc.,kali sulph., ycopodium, merc. viv., mezereum,phosphorus, plantago, pulsatilla, silicea,verbascum, echinacea, hydrastis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1504 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Influenza A Virus (UNII: R9HH0NDE2E) (Influenza A Virus - UNII:R9HH0NDE2E) Influenza A Virus 30 [hp_X] in 1 mL Tellurium (UNII: NQA0O090ZJ) (Tellurium - UNII:NQA0O090ZJ) Tellurium 15 [hp_X] in 1 mL Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 10 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X] in 1 mL Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 10 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 10 [hp_X] in 1 mL Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 10 [hp_X] in 1 mL Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum 10 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 10 [hp_X] in 1 mL Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top 10 [hp_X] in 1 mL Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top 10 [hp_X] in 1 mL Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate 10 [hp_X] in 1 mL Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide 10 [hp_X] in 1 mL Potassium Sulfate (UNII: 1K573LC5TV) (Sulfate Ion - UNII:7IS9N8KPMG) Potassium Sulfate 10 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X] in 1 mL Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 10 [hp_X] in 1 mL Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark 10 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 10 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 10 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X] in 1 mL Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 10 [hp_X] in 1 mL Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 10 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 mL Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 3 [hp_X] in 1 mL Influenza B Virus (UNII: 1314JZ2X6W) (Influenza B Virus - UNII:1314JZ2X6W) Influenza B Virus 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-1504-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-1504-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-1504-0 .5 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-1504)