EARACHE- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid
Starkey Hearing Technologies

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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EarAche Drops

Drug Facts

Active ingredients

Belladonna 30C HPUS (less than 0.000000000001 % Alkaloids)

Calcarea Carbonica 30C HPUS

Chamomilla 30C HPUS

Lycopodium 30C HPUS

Pulsatilla 30C HPUS

Sulphur 30C HPUS

Purpose

Fever

Throbbing ear pain

Occasional sleeplessness and irritability

Ear pain

Ear itching, pain worse at night

Ear pain with burning

Uses

Temporarily relieves the symptoms of fever, pain, throbbing, irritability and sleeplessness associated with earaches after diagnosis by a physician. Relieves common pain and itching.

Warnings

Keep away from eyes. Do not take by mouth. Earache drops are only to be used in the ears. Tip of applicator should not enter ear canal.

As with any drug, ask a doctor before use if pregnant or breastfeeding.

Consult a physician if:

Symptoms persist for more than 48 hours
Discharge from the ear is present

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately

In case of emergency, contact a medical professional or Poison Control Center immediately.

Directions

Adults and children 2 years and up: Tilt head sideways and apply 3-4 drops into involved ear 4 times daily or as needed. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in.

Inactive ingredients

Citric acid, glycerine, purified water, sodium benzoate.

Tamper Evident. Do not use if neckband on bottle is broken or missing.

Questions or comments?

877-373-4034

Principal Display Panel - 10mL Carton Label

NDC 70903-300-10

HOMEOPATHIC

Natural Relief

Starkey®

Hearing Technologies

EarAche

Drops

0.33 FL OZ (10 mL)

Principal Display Panel - 10mL Bottle Label

NDC 70903-300-10

HOMEOPATHIC

TAMPER-EVIDENT. Do not use if neckband on bottle is broken or missing

Natural Relief

Starkey®

Hearing Technologies

EarAche

Drops

0.33 FL OZ (10 mL)

EARACHE
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70903-300
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	30 [hp_C] in 1 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	30 [hp_C] in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	30 [hp_C] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C] in 1 mL
ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD)	ANEMONE PATENS	30 [hp_C] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70903-300-10	1 in 1 BOX	12/01/2016	12/31/2018
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/01/2016	12/31/2018

Labeler - Starkey Hearing Technologies (055461479)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(70903-300) , pack(70903-300)

Name	Address	ID/FEI	Business Operations
Establishment
Lifetech Resources		622559110	manufacture(70903-300) , pack(70903-300) , label(70903-300)

Revised: 11/2018

Document Id: 7bd5c6a7-7a80-1432-e053-2991aa0a60a4

Set id: 9fadec5a-dedd-471b-8551-65fd73b5cf7f

Version: 4

Effective Time: 20181129

Starkey Hearing Technologies