Walgreens Earache Drops
FDA Label NDC 0363-2120

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co for the product Walgreens Earache Drops (NDC 0363-2120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor if, when using this product, keep out of the reach of children, directions for use in the ear only, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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 

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.

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.

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 

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

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. 

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

Principal Display Panel -Bottle Label 0.34 Floz

Walgreen NDC 0363-2120-42

Earache Drops

Homoepathic

  • Releives Pain
  • Calms Irritability

    • 0.34 FLOZ (10ml)

    Principal Display Panel -bottle Label 0.34 Floz (790851 Wag Ee 982772 Earachedrops Lab)

    Principal Display Panel -bottle Label 0.34 Floz (790851 Wag Ee 982772 Earachedrops Lab)

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 Box Label 0.34 Floz (5551999 Wag Ee 982772 Earachedrops Box)

    Principal Display Panel Box Label 0.34 Floz (5551999 Wag Ee 982772 Earachedrops Box)

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