Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 43b91ab6-3588-480d-a180-0239043da2e9
Route
TOPICAL
Published
Effective Date 2019-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (30 [hp_C]) Oyster Shell Calcium Carbonate, Crude Matricaria Chamomilla Lycopodium Clavatum Spore Anemone Pulsatilla Sulfur
Inactive Ingredients
Glycerin Benzalkonium Chloride Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-02-10

Description

Belladonna 30C HPUS, Calcarea Carbonica 30C HPUS, Chamomilla 30C HPUS, Lycopodium Clavatum 30C HPUS, Pulsatilla 30C HPUS, Sulphur 30C HPUS

Purpose

Fever, Throbbing ear pain, Sleeplessness and irritability, Ear pain, Ear itching pain worse at night , Ear pain with burning 


Medication Information

Purpose

Fever, Throbbing ear pain, Sleeplessness and irritability, Ear pain, Ear itching pain worse at night , Ear pain with burning 

Description

Belladonna 30C HPUS, Calcarea Carbonica 30C HPUS, Chamomilla 30C HPUS, Lycopodium Clavatum 30C HPUS, Pulsatilla 30C HPUS, Sulphur 30C HPUS

Uses

For use I ear only, according to homeopathic indications these ingredients temporaily relieve the symptoms of  fever, pain, throbbing and sleeplessness, with ear aches after diagnosis by a physician. Relieves common pain and itching due ot cold and flu "swimmers ear "& allergies.

purpose

Fever, Throbbing ear pain, Sleeplessness and irritability, Ear pain, Ear itching pain worse at night , Ear pain with burning 

warnings

Use only after diagonsis by a physcian and under the supervisor or a physcian

Keep away from eyes

  • this product is intended or compliment , not replace standard medical treatment 
  • initial worsening of symptoms may occur
  • A Physician should always be consulted to rule out serious causes 

If pregnant or breast feeding, ask a health care professional before use.

Active Ingredient

Belladonna 30C HPUS, Calcarea Carbonica 30C HPUS, Chamomilla 30C HPUS, Lycopodium Clavatum 30C HPUS, Pulsatilla 30C HPUS, Sulphur 30C HPUS

other Information
  • Protect from light and excessive moisture 
  • Active ingredient are micro dilutions in accordance with the Homeopathic Pharmacopeia of the United States and are therefore non toxic with no known side effects 
inactive Ingredients

 Benzalkonium Chloride, Citric Acid, Glycerin, Water

When Using This Product 
  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor
Stop Use and Ask A Doctor If
  • Symptoms worsenor continue for more than 48 hours 
  • There is dischare for the ear
  • A fever greater than 102°F is present

Do not use 

  • If if you have irritation, discharge or rash in the ear, consult a physician 
  • with ear tube, damaged ear drums or after surgery 
  • If product becomes cloudy 
keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

directions for Use in the Ear Only

  • Adults and children over the age of 2 years :  
  • For use in the ear only 
  • Remove any hearing aids before using this product
  • Use 3 to 5 drops twice per day or as needed 
  • Warm the content to body temperature by holding in your hands
  • Tilt head sideways and let solution drip into ear.
  • Tip of applicator should not enter ear canal. 
  • Keep drops in ear for 1 to 2 minutes by keeping head tilted or placing cotton in the ear. 
Principal Display Panel Box Label 0.34 Floz

Walgreens NDC 0363-2120-42

Eareache Drops 

Homoepathic

  • Relieves Pain
  • Calms Irritability 

0.34 FLOZ (10ml)

Principal Display Panel Bottle Label 0.34 Floz

Walgreen NDC 0363-2120-42

Earache Drops

Homoepathic

  • Releives Pain
  • Calms Irritability

0.34 FLOZ (10ml)


Structured Label Content

Uses

For use I ear only, according to homeopathic indications these ingredients temporaily relieve the symptoms of  fever, pain, throbbing and sleeplessness, with ear aches after diagnosis by a physician. Relieves common pain and itching due ot cold and flu "swimmers ear "& allergies.

purpose (Purpose)

Fever, Throbbing ear pain, Sleeplessness and irritability, Ear pain, Ear itching pain worse at night , Ear pain with burning 

warnings (Warnings)

Use only after diagonsis by a physcian and under the supervisor or a physcian

Keep away from eyes

  • this product is intended or compliment , not replace standard medical treatment 
  • initial worsening of symptoms may occur
  • A Physician should always be consulted to rule out serious causes 

If pregnant or breast feeding, ask a health care professional before use.

Active Ingredient (Active ingredient)

Belladonna 30C HPUS, Calcarea Carbonica 30C HPUS, Chamomilla 30C HPUS, Lycopodium Clavatum 30C HPUS, Pulsatilla 30C HPUS, Sulphur 30C HPUS

other Information (Other information)
  • Protect from light and excessive moisture 
  • Active ingredient are micro dilutions in accordance with the Homeopathic Pharmacopeia of the United States and are therefore non toxic with no known side effects 
inactive Ingredients (Inactive ingredients)

 Benzalkonium Chloride, Citric Acid, Glycerin, Water

When Using This Product  (When using this product )
  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor
Stop Use and Ask A Doctor If (Stop Use and ask a Doctor if)
  • Symptoms worsenor continue for more than 48 hours 
  • There is dischare for the ear
  • A fever greater than 102°F is present

Do not use 

  • If if you have irritation, discharge or rash in the ear, consult a physician 
  • with ear tube, damaged ear drums or after surgery 
  • If product becomes cloudy 
keep Out of the Reach of Children (Keep out of the reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

directions for Use in the Ear Only (Directions FOR USE IN THE EAR ONLY)

  • Adults and children over the age of 2 years :  
  • For use in the ear only 
  • Remove any hearing aids before using this product
  • Use 3 to 5 drops twice per day or as needed 
  • Warm the content to body temperature by holding in your hands
  • Tilt head sideways and let solution drip into ear.
  • Tip of applicator should not enter ear canal. 
  • Keep drops in ear for 1 to 2 minutes by keeping head tilted or placing cotton in the ear. 
Principal Display Panel Box Label 0.34 Floz (Principal Display Panel Box label 0.34 FLOZ)

Walgreens NDC 0363-2120-42

Eareache Drops 

Homoepathic

  • Relieves Pain
  • Calms Irritability 

0.34 FLOZ (10ml)

Principal Display Panel Bottle Label 0.34 Floz (Principal Display Panel -Bottle Label 0.34 FLOZ)

Walgreen NDC 0363-2120-42

Earache Drops

Homoepathic

  • Releives Pain
  • Calms Irritability

0.34 FLOZ (10ml)


Advanced Ingredient Data


Raw Label Data

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