FDA Label for Earache Relief Pm
View Indications, Usage & Precautions
Earache Relief Pm 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
Apis mellifica HPUS 6x, 12x, 18x...........................Discomfort, redness of external ear
Arnica montana HPUS 6x, 12x, 18x.......................Bruised aching pain
Calcarea phosphorica HPUS 8x, 12x, 18x.............Itching, irritability
Chamomilla HPUS 12x,18x....................................Pain disturbs sleep, restlessness
Echinacea HPUS 3x...............................................Immune support
Hepar sulphuris calcareum HPUS 8x, 12x, 18x......Sensitive to touch, water, wind, cold
Hoitzia HPUS 6x, 12x, 18x......................................Fever, fullness
Passiflora HPUS 5x ................................................Sleep disorders, exhaustion
Valeriana officinalis HPUS 6x..................................Relaxing, calming sleep aid
"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Apis mellifica HPUS - Discomfort, redness of external ear
Arnica montana HPUS - Bruised aching pain
Calcarea phosphorica HPUS - Itching, irritability
Chamomilla HPUS - Pain disturbs sleep, restlessness
Echinacea HPUS - Immune support
Hepar sulphuris calcareum - Sensitive to touch, water, wind, cold
Hoitzia HPUS - Fever, fullness
Passiflora HPUS - Sleep disorders, exhaustion
Valeriana officinalis HPUS - Relaxing, calming sleep aid
Indications & Usage
Uses:*
• According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Discomfort • Itching, coldness, irritability • Sensitivity to water, wind and touch • Fullness, congestion • Sleeplessness; 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.
*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.
- In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
- Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Do Not Use
Do not use:
- If solution changes color or becomes cloudy.
- If you have ear drainage, discharge, irritation, a rash in the ear or dizziness.
- If you have ear tubes, after surgery or with damaged ear drums.
Keep Out Of Reach Of Children
Keep out of reach of children
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.•Use 3 to 5 drops before bedtime. • 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 15o to 30o C (59o to 86o 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. • EarAche Relief ® PM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.
Inactive Ingredient
Inactive Ingredients:
Benzalkonium Chloride, Glycerin, Purified Water.
Questions Or Comments?
www.thereliefproducts.com, 1-888-969-6855
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.