WALGREENS EARACHE DROPS- hpus earache drops solution/ drops

Walgreens Earache Drops by

Drug Labeling and Warnings

Walgreens Earache Drops by is a Homeopathic medication manufactured, distributed, or labeled by Walgreens Co, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Box label 0.34 FLOZ

Walgreens NDC: 0363-2120-42

Eareache Drops 

Homoepathic

• Relieves Pain
• Calms Irritability 

0.34 FLOZ (10ml)

INGREDIENTS AND APPEARANCE

WALGREENS EARACHE DROPS 
hpus earache drops solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-2120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_C]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	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 PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-2120-42	1 in 1 CARTON	02/10/2018
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/10/2018

Labeler - Walgreens Co (008965063)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(0363-2120)