The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Hylands Naturals Earache Drops (NDC 54973-4124). 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, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Active ingredients | Purpose* |
| Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) | ear pain |
| Calcarea Carbonica 30C HPUS | ear pain, sensitivity to cold |
| Chamomilla 30C HPUS | ear pain, sensitivity to
drafts, plugged ears |
| Lycopodium 30C HPUS | ear pain |
| Pulsatilla 30C HPUS | ear itching |
| Sulphur 30C HPUS | ear pain with burning,
sensitivity to water |
HPUS" is the Homeopathic Pharmacopoeia of the
United States.
Temporarily relieves:
■ common pain or itching from swimmer’s ear
■ clogged ears
■ ear pain or itching from other earaches,
after diagnosis by a physician
Keep away from eyes.
Do not use if you have ear tubes, damaged ear drums or after ear surgery.
Stop use and ask a doctor if:
■ symptoms persist for more than 48 hours or worsen.
■ any discharge from ear is present.
■ symptoms are accompanied by a fever.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children.
Adults and children ages
4 years and over:
■ Tilt head sideways and apply
3-4 drops into involved ear
(tip of applicator should not
enter ear canal).
■ Keep head tilted for at least
2 minutes to keep drops in ear.
■ Repeat until relieved, up to
4 times per day.
■ Use as directed.
■ Do not refrigerate.
■ Shake well before using.
Citric Acid, Glycerine, Purified Water.
www.hylands.com
or [email protected]
DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician
Hyland's Naturals
Earache Drops 0.33 FL. OZ. (10 mL)
Carton (Ears0.33ctn)
Label (Ears0.33lb)
* Please review the disclaimer below.
