Active Ingredient
Chamomilla 10X
Mercurius solubilis 15X
Sulphur 12X
Homeopathic Ear Pain Relief
FDA Label NDC 0363-9020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co for the product Homeopathic Ear Pain Relief (NDC 0363-9020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, do not use:, stop use and ask a doctor if:, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
calmative, pain reliever
pain reliever
pain reliever, anti-itch
Uses:
According to homeopathic principles, the active ingredinets in this medication provide temporary relief from earache (ear pain) in children and adults due to:
- Drafts
- Colds
- Flu
- Swimmer's ear
Warnings:
- For external use only- A physician should be consulted about earache in children.- Initial exacerbation of symptoms may occur.- Keep this and all medicines 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, discharge, irritation, a rash in the ear, or are dizzy; consult a doctor.- With ear tubes, after ear surgery or with damaged ear drums.
Stop Use And Ask A Doctor If:
- Symptoms persist for more than 48 hours.- These is discharge from the ear.- There is a fever of 102F or greater.
Directions:
FOR USE IN THE EAR ONLYFor adults and children, including toddlers and infants:- Remove tamper-evident seal from neck of bottle.- Twist cap off bottle.- Tilt head sideways.- Squeeze plastic applicator to release 2-3 drops into ear (applicator should not enter ear canal).- Keep drops in ear by keeping head tilted or placing cotton in ear.- Repeat as needed, use when pain recurs.
Other Information:
Active ingredients are manufactured according to homeopathic principles and are therefore non-toxic and have no known side effects.
Inactive Ingredient:
Vegetable glycerin
Principle Display Panel
NDC 0363-9020-11
W
Homeopathic
Ear Pain Relief
Ear Drops
10 ml/ 0.33 fl oz
Walgreens Ear Pain Relief Box (Homeopathic Ear Pain Relief 1)
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