Ear Care Earache Drops

Ear Care Earache Drops
SPL v2
SPL
SPL Set ID 58f1f79f-f1dd-3094-e053-2991aa0ac591
Route
AURICULAR (OTIC)
Published
Effective Date 2018-03-16
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
Citric Acid Monohydrate Water Benzalkonium Chloride Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-08-03

Description

Drug Facts


Medication Information

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 44425-7

• Store at 15°C-30°C (59°F-86°F)

• Protect from light and excessive moisture

Section 50565-1

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

Section 50569-3

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
Section 50570-1

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.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
"HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States.
Belladonna 30C HPUS Fever
Calcarea Carbonica 30C HPUS Throbbing ear pain
Chamomilla 30C HPUS Sleeplessness and irritability
Lycopodium 30C HPUS Ear pain
Pulsatilla 30C HPUS Ear itching, pain worse at night
Sulphur 30C HPUS Ear pain with burning
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.

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.

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.

Inactive Ingredients

Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

Questions Or Comments?

(800) RITE-AID

(800-748-3243)

Principal Display Panel 10 Ml Bottle Carton

NDC 11822-3644-3

ear care

earache drops

homeopathic



eases pain

calms and soothes

relieves itching due to

cold & flu, swimmers

ear & allergy

0.33 FL. OZ. (10 mL)


Structured Label Content

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.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

• Store at 15°C-30°C (59°F-86°F)

• Protect from light and excessive moisture

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
"HPUS" indicates the components of this product are officially monographed in the Homeopathic Pharmacopœia of the United States.
Belladonna 30C HPUS Fever
Calcarea Carbonica 30C HPUS Throbbing ear pain
Chamomilla 30C HPUS Sleeplessness and irritability
Lycopodium 30C HPUS Ear pain
Pulsatilla 30C HPUS Ear itching, pain worse at night
Sulphur 30C HPUS Ear pain with burning
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.

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.

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.

Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride, Citric Acid, Glycerine, Purified Water

Questions Or Comments? (Questions or comments?)

(800) RITE-AID

(800-748-3243)

Principal Display Panel 10 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton)

NDC 11822-3644-3

ear care

earache drops

homeopathic



eases pain

calms and soothes

relieves itching due to

cold & flu, swimmers

ear & allergy

0.33 FL. OZ. (10 mL)


Advanced Ingredient Data


Raw Label Data

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