FDA Label for Hylands Naturals Earache Drops
View Indications, Usage & Precautions
Hylands Naturals Earache Drops Product Label
The following document was submitted to the FDA by the labeler of this product Hyland's Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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.
Uses*
Temporarily relieves:
■ common pain or itching from swimmer’s ear
■ clogged ears
■ ear pain or itching from other earaches,
after diagnosis by a physician
Warnings
Keep away from eyes.
Otc - Do Not Use
Do not use if you have ear tubes, damaged ear drums or after ear surgery.
Otc - Ask Doctor
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
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.
Inactive Ingredients
Citric Acid, Glycerine, Purified Water.
Questions?
www.hylands.com
or [email protected]
Other Safety Information
DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
Otc - Purpose
Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician
Principal Display Panel
Hyland's Naturals
Earache Drops 0.33 FL. OZ. (10 mL)
* Please review the disclaimer below.