FDA Label for Equate Homeopathic Earache Drops
View Indications, Usage & Precautions
Equate Homeopathic Earache Drops Product Label
The following document was submitted to the FDA by the labeler of this product Walmart 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 Pharmacopœia 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 - Stop Use
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. If swallowed, contact a medical professional or Poison Control Center (1-800-222-1222) right away.
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, Glycerin, Purified Water.
Otc - Questions
1-888-287-1915
Other
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
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
NDC 79903-198-01
equate™
Compare
to Hyland's
Earache
Drops active
ingredients
HOMEOPATHIC
Earache
Drops*
- Relieves ear pain & clogging*
- Swimmer's ear*
- Cold & flu*
- Allergy*
0.33 FL OZ (10mL)
*CLAIMS BASED ON TRADITIONAL
HOMEOPATHIC PRACTICE, NOT
ACCEPTED MEDICAL EVIDENCE. NOT
FDA EVALUATED.
* Please review the disclaimer below.