EAR CARE- influenzinum, tellurium metallicum, apis mel., arsenicum alb., belladonna, bryonia, capsicum, causticum, cinchona, con

United States - English - NLM (National Library of Medicine)

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Active ingredient:
INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E), TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ), APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z), ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV), ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B), CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG), CAUSTICUM (U
Available from:
Newton Laboratories, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure. Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.
Authorization status:
unapproved homeopathic
Authorization number:
55714-2424-0, 55714-2424-1

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

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.

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EarCa 2424L

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. Sensitive persons begin with 1 drop and gradually increase to

full dose.

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, 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

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55714-2424

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

INFLUENZA A VIRUS (UNII: R9 HH0 NDE2E) (INFLUENZA A VIRUS - UNII:R9 HH0 NDE2E)

INFLUENZA A VIRUS

30 [hp_X]

in 1 mL

TELLURIUM (UNII: NQA0 O0 9 0 ZJ) (TELLURIUM - UNII:NQA0 O0 9 0 ZJ)

TELLURIUM

15 [hp_X]

in 1 mL

APIS MELLIFERA (UNII: 7S8 2P3R43Z) (APIS MELLIFERA - UNII:7S8 2P3R43Z)

APIS MELLIFERA

15 [hp_X]

in 1 mL

ARSENIC TRIO XIDE (UNII: S7V9 2P6 7HO) (ARSENIC CATION (3+) - UNII:C9 6 6 13F5AV)

ARSENIC TRIOXIDE

15 [hp_X]

in 1 mL

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

15 [hp_X]

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

15 [hp_X]

in 1 mL

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT -

UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

15 [hp_X]

in 1 mL

CAPSICUM (UNII: 0 0 UK76 46 FG) (CAPSICUM - UNII:0 0 UK76 46 FG)

CAPSICUM

15 [hp_X]

in 1 mL

CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)

CAUSTICUM

15 [hp_X]

in 1 mL

CINCHO NA O FFICINALIS BARK (UNII: S0 0 3A158 SB) (CINCHONA OFFICINALIS BARK

- UNII:S0 0 3A158 SB)

CINCHONA OFFICINALIS

BARK

15 [hp_X]

in 1 mL

CO NIUM MACULATUM FLO WERING TO P (UNII: Q28 R5GF371) (CONIUM

MACULATUM FLOWERING TOP - UNII:Q28 R5GF371)

CONIUM MACULATUM

FLOWERING TOP

15 [hp_X]

in 1 mL

SO LANUM DULCAMARA TO P (UNII: KPS1B116 2N) (SOLANUM DULCAMARA TOP -

UNII:KPS1B116 2N)

SOLANUM DULCAMARA

15 [hp_X]

in 1 mL

FERRO SO FERRIC PHO SPHATE (UNII: 9 1GQH8 I5F7) (FERROSOFERRIC PHOSPHATE -

UNII:9 1GQH8 I5F7)

FERROSOFERRIC

PHOSPHATE

15 [hp_X]

in 1 mL

CALCIUM SULFIDE (UNII: 1MBW0 7J51Q) (CALCIUM SULFIDE - UNII:1MBW0 7J51Q)

CALCIUM SULFIDE

15 [hp_X]

in 1 mL

PO TASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9 N8 KPMG)

POTASSIUM SULFATE

15 [hp_X]

in 1 mL

LYCO PO DIUM CLAVATUM SPO RE (UNII: C8 8 X29 Y479 ) (LYCOPODIUM CLAVATUM

SPORE - UNII:C8 8 X29 Y479 )

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: X2N6 E40 5GV) (DAPHNE MEZEREUM BARK -

UNII:X2N6 E40 5GV)

DAPHNE MEZEREUM BARK

15 [hp_X]

in 1 mL

PHO SPHO RUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)

PHOSPHORUS

15 [hp_X]

in 1 mL

PLANTAGO MAJO R (UNII: W246 9 WNO6 U) (PLANTAGO MAJOR - UNII:W246 9 WNO6 U)

PLANTAGO MAJOR

15 [hp_X]

in 1 mL

PULSATILLA VULGARIS (UNII: I76 KB35JEV) (PULSATILLA VULGARIS -

UNII:I76 KB35JEV)

PULSATILLA VULGARIS

15 [hp_X]

in 1 mL

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6 XBU4)

SILICON DIOXIDE

15 [hp_X]

in 1 mL

VERBASCUM THAPSUS (UNII: C9 TD27U172) (VERBASCUM THAPSUS -

UNII:C9 TD27U172)

VERBASCUM THAPSUS

15 [hp_X]

in 1 mL

ECHINACEA, UNSPECIFIED (UNII: 4N9 P6 CC1DX) (ECHINACEA, UNSPECIFIED -

UNII:4N9 P6 CC1DX)

ECHINACEA, UNSPECIFIED

6 [hp_X]

in 1 mL

GO LDENSEAL (UNII: ZW3Z11D0 JV) (GOLDENSEAL - UNII:ZW3Z11D0 JV)

GOLDENSEAL

6 [hp_X]

in 1 mL

INFLUENZA B VIRUS (UNII: 1314JZ2X6 W) (INFLUENZA B VIRUS - UNII:1314JZ2X6 W)

INFLUENZA B VIRUS

30 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:55714-2424-

30 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/31/20 19

2

NDC:55714-2424-

15 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/31/20 19

0 8 /0 1/20 19

Newton Laboratories, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 1/31/20 19

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newto n Labo rato ries, Inc.

78 8 79 36 10

ma nufa c ture (55714-2424)

Revised: 9/2019

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