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- NDC Code(s): 36800-846-07
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated February 28, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- Drug Facts
- Active ingredients
Chamomilla 10X
Mercurius solubilis 15X
Sulphur 12X
Purpose
sensitivity to dreafts, soothing
fullness, sensitivity to cold
itchiness, sensitivity to water
- Uses
Helps relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.
- Warnings
Do not use
- in the eyes.
- Initial exacerbation may occur.
Ask a doctor before use if you have:
- ear drainage or discharge
- pain, irritation, or rash in the ear
- had ear surgery
- dizziness
Stop use and ask a doctor if:
- irritation (too much burning) or pain occurs
- symptoms persist for more than 48 hours
If pregnant or breast feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away.
- Directions
FOR USE IN THE EAR ONLY.
- Remove tamper-evident seal from neck of bottle.
- Twist cap off bottle.
- Tilt head sideways.
- Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).
- Keep drops in ear by keeping head tilted or placing cotton in ear.
- Use up to 4 times daily for no more than 48 hours, or as direted by a doctor.
- Children under 12 years of age consult a doctor.
- Other information
- Active ingredients are manufactured according to homeopathic principles.
- Do not use if tamper-evident safety seal is missing orbroken.
- Inactive ingredient
Vegetable glycerin
- Questions?
1-888-423-0139
- Package Labeling:
- INGREDIENTS AND APPEARANCE
TOP CARE EAR RELIEF EAR DROPS
chamomile, mercurius solubilis, sulfur solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-846 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 10[hp_X] in1mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 15[hp_X] in1mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12[hp_X] in1mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-846-07 1 in 1 BOX 07/01/2007 1 12 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2007 Labeler -Topco Associates LLC(006935977)
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Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
TOP CARE EAR RELIEF EAR DROPS- chamomile, mercurius solubilis, sulfur solution/ drops
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Mar 6, 2025 | 2 (current) | download |
| Mar 2, 2021 | 1 | download |
RxNorm
TOP CARE EAR RELIEF EAR DROPS- chamomile, mercurius solubilis, sulfur solution/ drops
Under Review - Editing is pending for RxNorm. If in scope, these drugs will include RxNorm normal forms when editing is complete.
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TOP CARE EAR RELIEF EAR DROPS- chamomile, mercurius solubilis, sulfur solution/ drops
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NDC Codes
TOP CARE EAR RELIEF EAR DROPS- chamomile, mercurius solubilis, sulfur solution/ drops
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 36800-846-07 |
