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NDC 11822-3644-03 EAR CARE EARACHE DROPS 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Details
EAR CARE EARACHE DROPS 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
EAR CARE EARACHE DROPS is a AURICULAR (OTIC) LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. The primary component is ANEMONE PULSATILLA; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SULFUR.
Product Information
| NDC | 11822-3644 |
|---|---|
| Product ID | 11822-3644_678c8e7e-1d5b-f12a-e053-2991aa0ab6cc |
| Associated GPIs | 99870010002030 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | EAR CARE EARACHE DROPS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, and SULFUR |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | AURICULAR (OTIC) |
| Active Ingredient Strength | 30; 30; 30; 30; 30; 30 |
| Active Ingredient Units | [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL |
| Substance Name | ANEMONE PULSATILLA; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SULFUR |
| Labeler Name | Rite Aid Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED HOMEOPATHIC |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 11822-3644-03 (11822364403)
| NDC Package Code | 11822-3644-3 |
|---|---|
| Billing NDC | 11822364403 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (11822-3644-3) / 10 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2017-08-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 58f1f79f-f1dd-3094-e053-2991aa0ac591 Details
SPL UNCLASSIFIED SECTION
| 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 |
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.
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
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:
PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| EAR CARE EARACHE DROPS
atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur liquid |
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| Labeler - Rite Aid Corporation (014578892) |