The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Childrens Earache Relief (NDC 59262-274). 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 otc - active ingredient, uses:, warnings:, do not use:, directions:, other information:, inactive ingredient:, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active Ingredients PurposeChamomilla 10X calmative, pain relieverMercurius solubilis 15X anti-inflammatory, pain relieverSulphur 12X pain reliver, anti-itch
Uses:
Uses:According to homeopathic principles, the active ingredinets in this medication provide temporary relief from earache (ear pain) in children due to:draftscoldsfluswimmer's ear
Warnings:
Warnings:For external use onlyA physician should be consulted about earache in children as a matter of principle.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:
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.
Directions:
Directions:FOR USE IN THE EAR ONLYFor infancts and children of all ages:remove tamper-evident seal from neck of bottletwist cap off bottletilt head sidewayssqueeze 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 earrepeat as needed, use when pain reoccurs
Other informationActive ingredients are micro diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects
Inactive Ingredient:
Inactive Ingredient:Vegetable glycerin
Questions?
Questions?Reach our representatives, M-F, 8am-5pm (MT), or our 24 hour recorded product information at 1-800-240-9780. Visit us: www.SimilasanUSA.com
Package Label.Principal Display Panel
HomeopathicNDC 59262-271-11SimilasanEarache Relief10 ml/ 0.33 fl oz
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