FDA Label for Swimmers Ear Complete Relief
View Indications, Usage & Precautions
Swimmers Ear Complete Relief Product Label
The following document was submitted to the FDA by the labeler of this product Trp Company. 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
Calcarea phosphorica HPUS 12X, 18X...............Itching, irritability
Hepar sulphuris calcareum HPUS 12X, 18X.......Sensitive to touch, water
Hoitzia HPUS 12X, 18X.......................................Fullness in the ear, water, pain and discomfort
Kali muriaticum HPUS 12X, 18X ........................Clogged ear
Mercurius solubilis HPUS 12X, 18X....................Swimmer's ear irritation
Valeriana officinalis HPUS 12X, 18X...................Relaxing, calming
"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Calcarea phosphorica HPUS - Itching, irritability
Hepar sulphuris calcareum HPUS - Sensitive to touch, water
Hoitzia HPUS - Fullness in the ear, water, pain and discomfort
Kali muriaticum HPUS - Clogged ear
Mercurius solubilis HPUS - Swimmer's ear irritation
Valeriana officinalis HPUS - Relaxing, calming
Indications & Usage
Uses:*
According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Sensitivity to touch in ear • Pain and discomfort • Water/Congestion in ear • Swimmer’s ear irritation; after serious causes have been ruled out by a physician.
*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Warnings
Warnings:
A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. For External Use Only.
- This product is intended to complement, not replace, standard medical treatment.
- Initial worsening of symptoms may occur.
Flammable: Keep away from fire or flame.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Do Not Use
Do not use: in the eyes. If contact occurs, rinse eyes thoroughly with water
Keep Out Of Reach Of Children
• Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:• Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physician before use. • For use in ear only. • Apply 4-5 drops in each affected ear. • Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. • Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 20 to 40 seconds. • Homeopathic remedies may not be effective for everyone. Individual results may vary.
Other
Other information:
• Non-prescription drug products cannot treat infections. • Store at room temperature 15° to 30° C (59° to 86°F). • Keep bottle tightly closed. • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Swimmer’s Ear Complete Relief TM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.
Inactive Ingredient
Inactive Ingredients:
Glycerin, Isopropyl alcohol 94%
Stop Use
Stop use and ask a doctor if: •You experience ear pain, irritation (too much burning) or worsening symptoms. • Your symptoms last longer than 7 days
Ask Doctor
Ask a doctor before use if you have: • Ear Drainage or discharge • pain, irritation, or a rash in the ear • dizziness • had ear surgery
Package Label.Principal Display Panel
FDA Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
* Please review the disclaimer below.