Walgreens EarAche TM Drops

Drug Labeling and Warnings

Drug Details [pdf]

WALGREENS EARACHE DROPS- atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur liquid 
TRP Company

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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Walgreens EarAche TM Drops

Drug Facts

Active ingredientsPurpose
"HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States.
Belladonna 30C HPUSFever
Calcarea Carbonica 30C HPUSThrobbing ear pain
Chamomilla 30C HPUSSleeplessness and irritability
Lycopodium 30C HPUSEar pain
Pulsatilla 30C HPUSEar itching, pain worse at night
Sulphur 30C HPUSEar pain with burning

Uses*

For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmers ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. Keep away from eyes. This product is intended to complement, 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 professional before use.

Stop and ask a doctor it:

  • Symptoms worsen or continue for more than 48 hours
  • There is discharge from the ear.
  • A fever of greater than 102° is present

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use: if you have ear drainage, irritation, discharge, or rash in the ear, consult a physician. With ear tubes, with damaged ear drums or after surgery. if drops become cloudy.

Directions

Suitable for adults and children over the age of 2.

For use in the ears only

Remove any hearing aids

Use 3-5 drops twice per day or as needed. Warm contents to body temperature by holding bottle in your hands. Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in. Tilt your head to the side and let solution drip into the ear. Never put the tip in the ear canal. Keep drops in your ear by tilting your head for 1-2 minutes or gently place cotton in the ear to keep drops in.

Inactive ingredients

Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

Questions or comments?

1-800-925-4733

Other Information:

Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopeia of the United States and are therefore non-toxic with no known side effects.

Store at 15°C-30°C (59°F-86°F)
Protect from light and excessive moisture

Walgreens EarAche TM Drops may be used to temporarily address the symptoms of the ear such as fever, pain, thobbing, irritability and sleeplessness. This healthy, natural formula quickly stimulates the body's natural ability to relieve these symptoms. The active ingredients work without known side effects and without known drug interactions.

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC: 17312-203-15


Relieves pain, calms

irritability & soothes

itching due to cold & flu,

swimmers ear & allergy

0.33 FL. OZ. (10 mL)

Carton

WALGREENS EARACHE DROPS 
atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 17312-203
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 17312-203-151 in 1 CARTON08/03/201701/15/2018
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/03/201701/15/2018
Labeler - TRP Company (105185719)

Revised: 5/2019
 

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