EAR RINGING- aconitum nap., baryta carb., baryta mur., capsicum, causticum, chenopodium anthelminticum, chininum sulphuricum, cinchona, glonoinum, graphites, hydrastis, kali bic., kali mur., lycopodium, phosphorus, pulsatilla, salicylicum ac., tabacum, thiosinaminum, viola odorata 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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EarRi 2426L

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times a day 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 Hydrastis 6x, Aconitum nap. 10x, Baryta carb. 10x, Baryta mur. 10x, Capsicum 10x, Causticum 10x, Chenopodium anthelminticum 10x, Chininum sulphuricum 10x, Cinchona 10x, Glonoinum 10x, Graphites 10x, Hydrastis 10x, Kali bic. 10x, Kali mur.10x, Lycopodium 10x, Phosphorus 10x, Pulsatilla 10x, Salicylicum ac.10x, Tabacum 10x, Thiosinaminum 10x, Viola odorata 10x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS: Keep out of reach of children.

PACKAGE LABEL

Package Label

EAR RINGING 
aconitum nap., baryta carb., baryta mur., capsicum, causticum, chenopodium anthelminticum, chininum sulphuricum, cinchona, glonoinum, graphites, hydrastis, kali bic., kali mur., lycopodium, phosphorus, pulsatilla, salicylicum ac., tabacum, thiosinaminum, viola odorata liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2426
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE10 [hp_X]  in 1 mL
BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN) BARIUM CHLORIDE DIHYDRATE10 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM10 [hp_X]  in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 1 mL
DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (DYSPHANIA AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES10 [hp_X]  in 1 mL
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE10 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN10 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL10 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE10 [hp_X]  in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE10 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 [hp_X]  in 1 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF10 [hp_X]  in 1 mL
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA10 [hp_X]  in 1 mL
VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA10 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2426-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2019
2NDC:55714-2426-250 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201901/01/2020
3NDC:55714-2426-015 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/201901/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2426)

Revised: 1/2020
Document Id: 9bb95991-6f82-9f63-e053-2a95a90a7073
Set id: 93024322-52a8-e31a-e053-2a95a90af95e
Version: 3
Effective Time: 20200109
 
Newton Laboratories, Inc.