Label: EARACHE RELIEF- chamomilla and mercurius solubilis and sulphur solution
- NDC Code(s): 53799-406-11
- Packager: Similasan AG
- 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 April 4, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients -
- Purpose
- Uses*
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Warnings
• Do not use in the eyes.
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222
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Directions
FOR USE IN THE EAR ONLY.
• Remove tamper-evident seal from neck of bottle.
• Twist cap off bottle.
• Tilt head sideways.
• DON'T squeeze bottle, squeeze plastic tip to release 3 to 5 drops into ear (Tip of applicator should not enter ear canal).
• Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.
• Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.
• Children under 12 years of age consult a doctor.
- Other information
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EARACHE RELIEF
chamomilla and mercurius solubilis and sulphur solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53799-406 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] in 10 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 15 [hp_X] in 10 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 10 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53799-406-11 10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/03/2023 Labeler - Similasan AG (481545754)