Ear Care: Homeopathic Product Information

EAR CARE- influenza a virus, tellurium, apis mellifera, arsenic trioxide, atropa belladonna, bryonia alba root, capsicum, causticum, cinchona officinalis bark, conium maculatum flowering top, solanum dulcamara top, ferrosoferric phosphate, calcium sulfide, potassium sulfate, lycopodium clavatum spore, mercury, daphne mezereum bark, phosphorus, plantago major, anemone pulsatilla, silicon dioxide, verbascum thapsus, echinacea, unspecified, goldenseal and influenza b virus liquid
Newton Laboratories, Inc.

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.

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

OTC — ACTIVE INGREDIENT SECTION

Equal parats of Echinacea 6x, Hydrastis 6x, Apis mel. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Capsicum 15x, Causticum 15x, Cinchona 15x, Conium 15x, Dulcamara 15x, Ferrum phos. 15x, Hepar sulph. calc. 15x, Kali sulph. 15x, Lycopodium 15x, Merc. viv. 15x, Mezereum 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Silicea 15x, Tellurium 15x, Verbascum 15x, Influenzinum 30x.

OTC — PURPOSE SECTION

Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

newtonlabs.net — Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 — Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC — PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding , ask a doctor before use.

OTC — KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label
(click image for full-size original)

EAR CARE
influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, causticum, cinchona, conium, dulcamara, ferrum phosphoricum, hepar sulph. calc.,kali sulph., lycopodium, merc. viv., mezereum, phosphorus, plantago, pulsatilla, silicea, verbascum, echinacea, hydrastis liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4784
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS (INFLUENZA A VIRUS) INFLUENZA A VIRUS 30 [hp_X] in 1 mL
TELLURIUM (TELLURIUM) TELLURIUM 15 [hp_X] in 1 mL
APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 15 [hp_X] in 1 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL
CAPSICUM (CAPSICUM) CAPSICUM 15 [hp_X] in 1 mL
CAUSTICUM (CAUSTICUM) CAUSTICUM 15 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL
CONIUM MACULATUM FLOWERING TOP (CONIUM MACULATUM FLOWERING TOP) CONIUM MACULATUM FLOWERING TOP 15 [hp_X] in 1 mL
SOLANUM DULCAMARA TOP (SOLANUM DULCAMARA TOP) SOLANUM DULCAMARA TOP 15 [hp_X] in 1 mL
FERROSOFERRIC PHOSPHATE (FERROSOFERRIC PHOSPHATE) FERROSOFERRIC PHOSPHATE 15 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 15 [hp_X] in 1 mL
POTASSIUM SULFATE (SULFATE ION) POTASSIUM SULFATE 15 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 mL
MERCURY (MERCURY) MERCURY 15 [hp_X] in 1 mL
DAPHNE MEZEREUM BARK (DAPHNE MEZEREUM BARK) DAPHNE MEZEREUM BARK 15 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 15 [hp_X] in 1 mL
PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 15 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 15 [hp_X] in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 15 [hp_X] in 1 mL
VERBASCUM THAPSUS (VERBASCUM THAPSUS) VERBASCUM THAPSUS 15 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL
INFLUENZA B VIRUS (INFLUENZA B VIRUS) INFLUENZA B VIRUS 30 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-4784-1 30 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/02/2019
Labeler — Newton Laboratories, Inc. (788793610)
Registrant — Newton Laboratories, Inc. (788793610)
Establishment
Name Address ID/FEI Operations
Newton Laboratories, Inc. 788793610 manufacture (55714-4784)

Revised: 12/2020 Newton Laboratories, Inc.

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